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Effects of a Digital Patient Empowerment and Communication Tool on Metabolic Control in People With Type 2 Diabetes: The DeMpower Multicenter Ambispective Study

Effects of a Digital Patient Empowerment and Communication Tool on Metabolic Control in People... Background: Diabetes is a major health care problem, reaching epidemic numbers worldwide. Reducing hemoglobin A 1c (HbA ) levels to recommended targets is associated with a marked decrease in the risk of type 2 diabetes mellitus (T2DM)–related 1c complications. The implementation of new technologies, particularly telemedicine, may be helpful to facilitate self-care and empower people with T2DM, leading to improved metabolic control of the disease. Objective: This study aimed to analyze the effect of a home digital patient empowerment and communication tool (DeMpower App) on metabolic control in people with inadequately controlled T2DM. Methods: The DeMpower study was multicenter with a retrospective (observational: 52 weeks of follow-up) and prospective (interventional: 52 weeks of follow-up) design that included people with T2DM, aged ≥18 and ≤80 years, with HbA levels 1c ≥7.5% to ≤9.5%, receiving treatment with noninsulin antihyperglycemic agents, and able to use a smartphone app. Individuals were randomly assigned (2:1) to the DeMpower app–empowered group or control group. We describe the effect of empowerment on the proportion of patients achieving the study glycemic target, defined as HbA ≤7.5% with a ≥0.5% reduction in HbA at 1c 1c week 24. Results: Due to the COVID-19 pandemic, the study was stopped prematurely, and 50 patients (33 in the DeMpower app–empowered group and 17 in the control group) were analyzed. There was a trend toward a higher proportion of patients achieving the study glycemic target (46% vs 18%; P=.07) in the DeMpower app group that was statistically significant when the target was HbA ≤7.5% (64% vs 24%; P=.02) or HbA ≤8% (85% vs 53%; P=.02). The mean HbA was significantly reduced 1c 1c 1c https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al at week 24 (−0.81, SD 0.89 vs −0.15, SD 1.03; P=.03); trends for improvement in other cardiovascular risk factors, medication adherence, and satisfaction were observed. Conclusions: The results suggest that patient empowerment through home digital tools has a potential effect on metabolic control, which might be even more relevant during the COVID-19 pandemic and in a digital health scenario. (JMIR Diabetes 2022;7(4):e40377) doi: 10.2196/40377 KEYWORDS empowerment; home digital tool; telemedicine; type 2 diabetes; diabetic; home based; home care; self-management; digital tool; metabolic; HbA; glycated hemoglobin; glycemic control; adherence; satisfaction; observational study; health app shown that the use of telemedicine is associated with Introduction improvements in patients’ outcomes such as adherence, pathology control, and engagement [21,23-27]. However, in Diabetes is a major health care problem, reaching epidemic Spain, there are few studies evaluating eHealth solutions for numbers worldwide [1,2]. Globally, approximately 537 million people with T2DM, mostly developed in small local settings people had type 2 diabetes mellitus (T2DM) in 2021, but it is [28-33]. expected that these numbers will increase up to nearly 783 million people by 2045 due to aging populations and the Taking into account the high prevalence and burden of T2DM negative impact of some lifestyles, such as obesity and in Spain and the current high number of people with inadequate sedentarism [1-3]. This translates into a huge socioeconomic metabolic control, developing innovative solutions to improve impact in addition to the health care burden [4]. In Spain, the this situation is necessary. This improvement should be made prevalence of T2DM is estimated to be approximately 14% [5], through patient empowerment by increasing self-management and the direct health costs of diabetes account for approximately and communication between patients and health care 8% of total public health expenditures [6]. professionals, allowing more effective T2DM control. Reducing hemoglobin A (HbA ) levels to recommended 1c 1c The aim of this study was to analyze the effect of a home digital targets is associated with a marked decrease in the risk of patient empowerment and communication tool (DeMpower T2DM-related complications [7]. Although adopting a healthy App) on metabolic control in people with T2DM and inadequate lifestyle (diet and physical activity) is necessary in T2DM to HbA levels compared to a control group, both treated 1c improve metabolic control, most people with T2DM will need according to usual clinical practice. at least 1 antidiabetic agent to control blood glucose levels. The pharmacological options to treat hyperglycemia in T2DM have Methods improved substantially over the past 20 years with the development of new therapeutic agents that not only safely Overview reduce HbA levels but also have cardiovascular and renal 1c The DeMpower study was a multicenter and an ambispective benefits; unfortunately, many people with T2DM do not achieve study including adults with T2DM having inadequate glycemic recommended HbA targets (<7%) [8,9]. In Spain, the 1c control, treated according to clinical practice across Spain. The proportion of people with T2DM with good glycemic control study population included people with T2DM aged ≥18 and has not improved markedly over the last decade, remaining at ≤80 years from Spanish health care sites with HbA levels 1c around 50%-60%, suggesting that additional approaches are ≥7.5% and ≤9.5%, who were receiving treatment with noninsulin warranted [10-12]. Moreover, the lockdown during the antihyperglycemic agents and who were able to use a COVID-19 pandemic has led to a worsening of follow-up and smartphone-based home digital tool. The main exclusion criteria metabolic control in people with T2DM globally and in Spain were the use of insulin treatments, pregnancy, any scheduled [13-16]. surgery, terminal or severe diseases, or any medical or psychological condition that, in the investigator’s opinion, might Although many causes have emerged to explain this poor have compromised the ability of the patient to provide informed metabolic control in people with T2DM, poor adherence to consent. Patients were recruited consecutively as they visited treatment and clinical inertia play a key role [17-19]. Therefore, the doctor’s office, reducing the possibility of selection bias proper management of T2DM is challenging and deserves and strengthening the generalizability of the results. constant attention and comprehensive patient-centered clinical assistance. Consequently, it is necessary to transform health The enrollment period was approximately 12 months and care systems to provide integrated and patient-centered chronic patients were followed up for 52 weeks. The primary end point care models [20]. was assessed at week 24 of follow-up. Retrospective data were collected during the 52 weeks prior to the baseline visit, and In this context, the implementation of new technologies, the HbA determination closest to the 24 weeks before baseline 1c particularly telemedicine, may be helpful to facilitate patient and the antidiabetic treatment prescribed at that time were self-care and empowerment [21,22]. In fact, effective diabetes recorded. After the enrollment period, patients were randomly self-management is a key goal, but it should be measured and assigned (2:1) to two comparative groups: group 1 (DeMpower monitored as part of routine care and technology may help app–empowered group), where patients were clinically managed patients and guide clinical decisions [22]. Different studies have https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al according to usual clinical practice and used the DeMpower satisfaction with the DeMpower app and experience with health app during the prospective study follow-up, and group 2 (control care received were also assessed. Finally, the mean number of group), where patients were clinically managed according to symptomatic and asymptomatic hypoglycemic events (≤70 usual clinical practice without the DeMpower app. After the mg/dL) registered at emergency departments from baseline to primary assessment at week 24, patients in group 1 were week 24 between groups 1 and 2 was determined. randomized again (1:1) to assess the durability of the effect at Questionnaires were used to evaluate study outcomes related week 52: group 1a (DeMpower app–empowered group, to the degree of physical activity (International Physical Activity long-term use), where patients kept using the DeMpower app, Questionnaire [IPAQ]), patient adherence to treatment and group 1b (DeMpower app–empowered group, short-term (Medication Adherence Report Scale [MARS-5]), satisfaction use), where patients stopped using the DeMpower app. Both with the DeMpower app (Diabetes Treatment Satisfaction groups continued being clinically managed according to usual Questionnaire status [DTSQs] version), and experience with clinical practice (Figure S1 in Multimedia Appendix 1). The health care received (Instrumento de Evaluación de la follow-up of group 2 continued without changes. eXperiencia del PAciente Crónico [IEXPAC]) [19,34-37]. In In group 1, patients received the following commercially this study, the short-form IPAQ was used, consisting of 4 available devices to use in combination with and connected to generic domains with 7 questions in total for use in either the DeMpower app: scale, glucometer, blood pressure monitor, interviews or self-administered methods [34]. The MARS-5 is and activity wristband. Patients were also trained to use the a 5-item scale that includes questions about the way patients devices according to routine clinical practice, as agreed with take their medicines and whether they forget to take them. their health care professionals (ie, taking periodic measurements Patients report agreement with statements about medicines using of their glucose and blood pressure levels as well as their weight a 5-point Likert scale (from “always” [scored as 1] to “never” and degree of physical activity). Data from these devices (body [scored as 5]). The maximum total score for all questions weight, glucose levels, blood pressure, and number of steps answered as “never” is 25 [35]. The DTSQs is an 8-item taken daily) were received wirelessly by the DeMpower app questionnaire, with 6 questions assessing treatment satisfaction for each patient and sent to the corresponding health care team and the other 2 assessing the perceived frequency of to review the patient’s activity and measurements, answer patient hyperglycemia and hypoglycemia. Each item is scored from 6 questions, and contact the patient, when needed (Figure S2 in (ie, very satisfied) to 0 (ie, very dissatisfied), with the treatment Multimedia Appendix 1). However, this channel of direct satisfaction scale ranging from 36 (ie, very satisfied) to 0 (ie, communication did not substitute clinical practice, and if health very dissatisfied) and the perceived frequency of hyperglycemia care was required due to an emergency, patients followed the and hypoglycemia scores ranging from 6 (ie, most of the time) usual procedure of going to the emergency department of to 0 (ie, none of the time) [36]. The IEXPAC is a 12-item scale primary care centers or hospitals. that includes 11 questions plus 1 more conditional question about the experience of patients with chronic conditions Patients in both groups received the same routine care and did regarding the health care and social attention that they have not undergo any interventions, whether diagnostic or monitoring, received. Items are answered as never (0 points), seldom (2.5 other than those planned according to routine clinical practice. points), sometimes (5 points), most times (7.5 points), and Clinical data and antidiabetic treatment details were collected always (10 points). The overall score of the 11 questions is from the clinical history of patients and from information calculated as their average score and ranges from 0 to 10. The provided by the patient during the study visit and entered into additional question (item 12) is reported separately and ranges the electronic case report form. Laboratory parameters, including from 0 to 10 [19,37]. HbA , low-density lipoprotein (LDL) cholesterol, and 1c Assuming a bilateral contrast, an alpha risk of .05, a power of high-density lipoprotein (HDL) cholesterol, were taken from 80%, a proportion of response of 50% for each group and a blood samples of all patients collected at baseline and thereafter, patient loss of ≤13%, 100 patients were needed in group 1 following local clinical practice until study completion or early (DeMpower app–empowered patients) and 50 patients in group study discontinuation. 2 (control group) to detect a difference equal to or higher than The main evaluations compared groups 1 and 2 at week 24. The 25% between both groups with regard to the primary study primary outcome of the study was to evaluate whether objective. For the descriptive analysis, quantitative variables empowerment would reduce the proportion of patients persisting were described with measures of centralization and dispersion without metabolic control at week 24. The primary study (mean and SD), whereas qualitative variables were described glycemic target was an HbA level ≤7.5% with a reduction in 1c by their absolute (N) and relative (%) frequencies. To compare HbA of ≥0.5% at week 24. Other secondary predefined study 1c 2 means between groups, parametric (Student t test) and glycemic targets were HbA ≤8%, HbA ≤7%, and nonparametric (Mann-Whitney U test) tests were used, as 1c 1c individualized HbA targets for each patient at week 24, as required. Categorical variables were compared with the 1c chi-square or the Fisher exact test, when appropriate. Hypothesis established by the investigators. The absolute HbA change at 1c tests were 2-tailed in all cases, with a significance level of .05. week 24 versus baseline was also a predefined secondary end The evolution of HbA throughout treatment was evaluated 1c point. In addition, mean changes in the body weight, BMI, blood using a general linear model of repeated measures. Absences pressure, LDL and HDL cholesterol levels, physical activity of data were not accounted for and were considered missing (measured as metabolic equivalent of task in min/week), and patient adherence to treatment were measured. Patient https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al data. Statistical analyses were performed using SPSS (version of patients using the DeMpower app, could have been affected 22.0 or higher; IBM Corp). by the generally altered lifestyles of the patients during and after the COVID-19 lockdown period, both in the empowered Ethics Approval and control groups. At the time of study discontinuation, 98 The study was approved by the following ethics committees: patients had been recruited in 15 of the 25 participating sites Institut Universitari d’Investigació en Atenció Primària Jordi across Spain. Among these, 9 patients were excluded, as they Gol (reference 5OB18/010), General University Hospital of did not meet the selection criteria and 89 were evaluable. Many Elda, Central Research Commission of Madrid, Murcian Health of the patients were not able to attend visits and procedures due Service, and Health Areas of León and Bierzo. to the lockdown, and finally, 50 patients (33 patients in group 1 and 17 patients in group 2) completed the study visit at week Results 24 and were considered valid for the final analysis of the main study end points. At week 52, the number of patients remaining Due to the COVID-19 pandemic, the study was stopped in groups 1a, 1b, and 2 were 6, 5, and 6, respectively (Figure prematurely (July 2020), with a relevant impact on both the 1). No patients abandoned the study due to an inability to adapt recruitment and follow-up of patients. In addition, the primary to the DeMpower app. hypothesis of the study, which was based on the empowerment Figure 1. Study flowchart. HbA : hemoglobin A ; IC: informed consent; T2DM: type 2 diabetes mellitus. 1c 1c The baseline clinical characteristics of the study population are cardiovascular disease being the most common (61% vs 47%, shown in Table 1. The groups were well balanced, without respectively; P=.39). At baseline, the mean (SD) HbA values 1c statistically significant between-group differences regarding were 8.2 (0.5) and 8.3 (0.6), respectively (P=.57). The most clinical characteristics or baseline treatments, except for the commonly prescribed antidiabetic drugs were metformin (88% presence of transient ischemic attack (no patients in group 1 vs vs 100%, respectively; P=.29), dipeptidyl peptidase-4 inhibitors 3 patients in group 2, P=.04) and the use of glinides (0 patients (61% vs 41%; P=.24), sodium-glucose cotransporter-2 inhibitors in group 1 vs 3 patients in group 2, P=.03). The mean age of (42% vs 53%; P=.56), and sulphonylureas (46% vs 18%; P=.40). the patients was 64 (SD 8) years, with 25% (13/50) older than Regarding the primary metabolic objective, there was a trend 69 years, and 50% (25/50) of all patients were aged between toward a higher proportion of people with T2DM achieving 59 and 69 years. Overall, 66% (33/50) were male and 96% HbA levels ≤7.5% with a reduction of ≥0.5% in HbA with 1c 1c (48/50) were Caucasian; the mean diabetes duration was 10 (SD 2 respect to the baseline value at week 24 (primary outcome) in 6) years, and the mean BMI was 29.7 (SD 4.9) kg/m . group 1 compared with that in group 2 (46% vs 18%; P=.07), Complications associated with diabetes were not observed in and this reached statistical significance when considering the 70% (23/33) of the patients in group 1 and 71% (12/17) of the proportion of people with T2DM achieving HbA levels ≤7.5% 1c patients in group 2 (P>.99). The majority of patients had at least at week 24 (64% vs 24%, respectively; P=.02; Figure 2). 1 comorbidity (70% vs 59%, respectively; P=.53), with https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al When analyzing the percentage of patients with HbA levels groups at week 24. In both groups, there was an overall increase 1c in the prescription of antidiabetic agents at week 24 (Table S1 ≤7% at week 24 (36% vs 12%, respectively; P=.1) or the in Multimedia Appendix 1). proportion of patients controlled according to the individualized HbA objectives for each patient established by the investigators 1c The evolution of the BMI, systolic blood pressure, diastolic (67% vs 82%, respectively; P=.33), no significant blood pressure, LDL, HDL, and physical activity from the between-group differences were observed. However, more baseline visit to week 24 is shown in Table S2 in Multimedia patients in group 1 achieved significant HbA levels ≤8% at 1c Appendix 1. Although no statistically significant between-group week 24 (85% vs 53%, respectively; P=.02; Figure 3). differences were observed, there was a positive trend for group 1, with relevant reductions in the BMI and blood pressure, and HbA levels from baseline to week 24 significantly decreased 1c an increase in physical activity. to a higher extent in group 1 versus group 2 (−0.81 [0.89] vs −0.15 [1.03]; mean difference −0.66%; P=.03). This statistically The MARS-5 responses showed similar adherence to treatment significant difference remained after adjusting for changes in in both groups at week 24, but with a positive trend in group 1. antidiabetic treatment, age, sex, duration of diabetes, smoking Patient satisfaction (DTSQs) and experience with the health status, socioeconomic status, educational level, and employment care system (IEXPAC) were positive in both groups, with no situation (Figure 4). significant between-group differences (Table S3 in Multimedia Appendix 1). No symptomatic and asymptomatic hypoglycemic events (≤70 mg/dL) from baseline to week 24 were reported in any of the Due to the small number of patients completing the week 52 groups at emergency departments both from primary care centers visit (17/50, 34%), no analysis was performed for the study and hospitals. With regard to antidiabetic drugs, there were no exploratory end points at this time. statistically significant differences in treatment between the https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Table 1. Baseline sociodemographic characteristics of patients completing 24 weeks of follow-up. Characteristic Group 1 (n=33) Group 2 (n=17) P value Age (years), mean (SD) 63.3 (6.4) 64.4 (9.5) .46 Sex (male), n (%) 22 (66.7) 11 (64.7) >.99 Race, n (%) >.99 Caucasian 32 (97) 16 (94.1) Other 1 (3.0) 1 (5.9) Educational level, n (%) .32 Primary 10 (30.3) 8 (47.1) Secondary 14 (42.4) 3 (17.6) Higher education 8 (24.2) 5 (29.4) Unknown 1 (3.0) 1 (5.9) Professional situation, n (%) .94 Unemployed 2 (6.1) 1 (5.9) Employee 9 (27.3) 4 (23.5) Autonomous 3 (9.1) 2 (11.8) Retired 17 (51.5) 8 (47.1) Other 2 (6.1) 2 (11.8) Lifestyle habits, n (%) .06 Active smoker 8 (24.2) 0 (0.0) Ex-smoker 15 (45.5) 8 (47.1) Never been a smoker 10 (30.3) 9 (52.9) Unknown 0 (0.0) 0 (0.0) 10.3 (7.3) 10.6 (4.6) .47 Time from T2DM diagnosis to study inclusion (years), mean (SD) Complications associated with T2DM disease, n (%) None 23 (69.7) 12 (70.6) >.99 Microalbuminuria 6 (18.2) 1 (5.9) .40 Peripheral vascular disease 3 (9.1) 1 (5.9) >.99 Ischemic heart disease 2 (6.1) 1 (5.9) >.99 Neuropathy 2 (6.1) 2 (11.8) .60 Stroke 1 (3.0) 3 (17.6) .11 Retinopathy 1 (3.0) 1 (5.9) >.99 Transient ischemic attack 0 (0.0) 3 (17.6) Heart failure 1 (3.0) 0 (0.0) >.99 Other complications 2 (6.1) 1 (5.9) >.99 ≥1 comorbidity, n (%) 23 (69.7) 10 (58.8) .53 Cardiovascular disease 20 (60.6) 8 (47.1) .39 Musculoskeletal disorder 10 (30.3) 5 (29.4) >.99 Endocrine disorder 7 (21.2) 3 (17.6) >.99 Neurological/psychiatric disorder 5 (15.2) 4 (23.5) .47 Gastrointestinal disorder 3 (9.1) 2 (11.8) >.99 Respiratory disease 5 (15.2) 2 (11.8) >.99 Hematological disease 4 (12.1) 0 (0.0) .29 https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Characteristic Group 1 (n=33) Group 2 (n=17) P value Renal disease 2 (6.1) 1 (5.9) >.99 Infectious disease 2 (6.1) 1 (5.9) >.99 Cancer 2 (6.1) 2 (11.8) .60 Autoimmune disease 1 (3.0) 0 (0.0) >.99 Physical examination, mean (SD) 30.2 (5.3) 28.7 (4.1) .40 BMI (Kg/m ) 137 (16.6) 130 (15.8) .26 SBP (mmHg) 79.5 (9.5) 76.1 (7.5) .08 DBP (mmHg) Laboratory parameters, mean (SD) 8.2 (0.5) 8.3 (0.6) .57 HbA (mg/dL) 1c Glucose 173.0 (35.3) 171.0 (38.9) .84 47.6 (18.1) 47.4 (11.2) .58 HDL cholesterol (mg/dL) 96.9 (29.7) 98.5 (34.6) .85 LDL cholesterol (mg/dL) Individualized HbA target 7.0 (0.2) 7.2 (0.3) .05 1c HbA (mg/dL), value closest to week 24 7.9 (0.9) 8.2 (1.0) .56 1c Antidiabetic drugs , n (%) Metformin 29 (87.9) 16 (94.1) .49 19 (57.6) 8 (47.1) .48 DPP-4 inhibitors 11 (33.3) 8 (47.1) .34 SGLT2 inhibitors Sulfonylurea 14 (42.4) 3 (17.6) .08 3 (9.1) 1 (5.9) .69 GLP1 receptor agonists Glinides 0 (0.0) 3 (17.6) .03 Glitazones 1 (3) 0 (0.0) .98 T2DM: type 2 diabetes mellitus. Italics indicate significant P values <.05. SBP: systolic blood pressure. DBP: diastolic blood pressure. HbA : hemoglobin A . 1c 1c HDL: high-density lipoprotein. LDL: Low-density lipoprotein. Patients may have been indicated as receiving more than one antidiabetic drug. DPP-4: dipeptidyl peptidase-4. SGLT2: sodium-glucose cotransporter-2. GLP1: glucagon-like peptide-1. https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Figure 2. Primary composite outcome and individual components. Primary composite outcome refers to the proportion of patients achieving the study glycemic target (HbA ≤7.5% with a reduction in HbA ≥0.5% with respect to baseline value) at week 24. HbA : hemoglobin A1c. 1c 1c 1c Figure 3. Proportion of patients with HbA ≤7%, HbA ≤8%, and individualized HbA target established by the investigator at week 24. HbA : 1c 1c 1c 1c hemoglobin A . 1c https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 8 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Figure 4. Changes in HbA from baseline to week 24. HbA : hemoglobin A . *Least square means with adjustments for changes in antidiabetic 1c 1c 1c treatment, age, sex, duration of diabetes, smoking status, socioeconomic status, educational level, and employment situation. significant for secondary outcomes such as HbA levels ≤7.5% 1c Discussion and ≤8% at week 24, as well as absolute HbA reduction at 1c week 24, even after adjusting for several clinical characteristics The results from this study suggest that patient empowerment including treatment modification. In particular, the 0.66% using the DeMpower app might improve metabolic control in difference in HbA levels between groups is clinically relevant people with T2DM who do not achieve HbA targets with the 1c 1c standard care, possibly leading to a more efficient management and was achieved without increasing the risk of hypoglycemia. of the disease. This is particularly remarkable given that there were no differences regarding the use or modification of antidiabetic The COVID-19 pandemic lockdown had a direct impact on the drugs between both groups. These results support the clinical recruitment and follow-up of patients, reducing the planned utility of the DeMpower app as a home digital patient study size. In addition, during lockdown, patients were not able empowerment and communication tool that might help patients to practice outdoor physical activities; some patients might have achieve glycemic control that is independent of the antidiabetic had uncontrolled dietary habits and physical access to health treatment. Similarly, previous studies have also shown the care providers was limited, leading to impaired metabolic control benefits of home-based digital patient empowerment tools in in both groups. Additionally, this could have also impacted the control of T2DM [23-33,43-47]. For example, the ValCrónic patient-reported outcomes (ie, physical activity, adherence, as study [30] showed that the proportion of people with HbA ≥8% 1c well as satisfaction and experience questionnaires). In fact, decreased significantly (by 44%) after 1 year of telemonitoring. many research projects unrelated to COVID-19 have been In our study, 85% of patients using the digital tool achieved substantialy reduced or even suspended due to legal restrictions HbA ≤8%, compared to 53% in the control group (absolute 1c or logistical, staffing, or operational concerns worldwide, as difference 32%; relative difference 60%; P=.02). Additionally, well as because of lockdowns or restrictions. Thus, a more meta-analyses of randomized controlled trials on telemedicine flexible approach that ensures participant safety is warranted interventions have confirmed significant improvements in the during the COVID-19 pandemic, under the good clinical practice management of diabetes compared with standard care [44,45]. umbrella [38]. In this context, investigating the impact of The use of home digital tools for people with T2DM telemonitoring and telemedicine in patients with chronic empowerment and metabolic control has become even more conditions such as T2DM should be considered a priority, as it important during the COVID-19 pandemic, as during this period, may facilitate better disease control [39,40]. metabolic control among people with T2DM has worsened The study groups were well balanced. The majority of patients [13-16]. In contrast, glycemic values in people with type 1 were aged >60 years, had at least 1 comorbidity, and were taking diabetes significantly improved during the COVID-19 lockdown, more than 1 antidiabetic drug. This is in line with the clinical which may be associated with positive changes in self-care and profiles reported in other studies of people with T2DM digital diabetes management [16]. This reinforces the importance [10,41,42], indicating that patients included in our study were of improving self-care management using digital tools in T2DM likely to be representative of the Spanish population with T2DM. and is in line with the DeMpower study results, suggesting that eHealth and telemedicine could reduce the negative impact of In our study, there was a trend in the primary outcome with a the COVID-19 pandemic and might be relevant in the digital higher numerical proportion of empowered patients achieving health framework. the study glycemic target at week 24 compared to those in the control group. The between-group differences were statistically https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 9 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al People with T2DM often present other comorbidities such as significant differences. Similar results have been previously hypertension, dyslipidemia, obesity, and renal or cardiovascular obtained regarding the information that patients receive or can disease [41,42]. Consequently, to reduce the cardiovascular access [19,37]. burden in T2DM, it is necessary to implement a comprehensive This study has some limitations. As noted earlier, the most approach that includes not only glycemic control but also blood relevant limitation is that the COVID-19 pandemic led to a pressure, lipid profile, body weight, and physical activity [48]. premature study termination, and consequently, the estimated In our study, there was a positive trend for some of these sample size of 150 patients could not be achieved. This might variables in patients who used the DeMpower app. Additionally, have impacted the statistical power for the assessment of the considering that the lockdown during COVID-19 had a negative main study outcome. As this study was designed to collect impact on metabolic and weight control [13-16], it is likely that information available in routine clinical practice at the with a larger sample size, these differences would have reached participating sites, some data were unavailable, limiting the statistical significance. Besides, a recent meta-analysis of 43 validity of the study results. Likewise, the appearance of bias studies reported a positive impact of telemedicine not only on derived from the unsuccessful use of digital tools could not be HbA but also on diastolic blood pressure, weight, and mental 1c ruled out, but this was expected to be minimized by the selection and physical quality of life, among people with T2DM [45]. of patients with a proven ability to use home mobile apps on Moreover, in the IDIATel randomized controlled trial [49] that their smartphones. compared telemedicine case management to routine care, greater In summary, the DeMpower study results strongly suggest that reductions in LDL cholesterol and systolic and diastolic blood patient empowerment through a home digital tool might lead pressure levels were achieved with telemedicine. to more effective metabolic control and consequently to more Patient satisfaction with treatment is important to improve effective achievement of the clinical objectives in people with medication adherence [50]. Although our study did not show T2DM. This study reinforces the importance of using significant differences between groups, previous studies have telemedicine and new technologies for patient empowerment shown an improvement with telemedicine [45]. Finally, the and metabolic control, especially in the digital health scenario. experience of patients regarding the health care attention Moreover, these findings appear to be crucial during situations received, evaluated with the IEXPAC tool, showed that there with limited patient access to health care and negative health was opportunity for improvement for both groups, without consequences, such as the COVID-19 pandemic. Acknowledgments The Spanish Diabetes Federation provided study endorsement and advice for the app design. Writing assistance was provided by Content Ed Net. This study was funded and sponsored by Merck Sharp & Dohme de España S.A (MSD Spain), a subsidiary of Merck & Co, Inc, Rahway, NJ. Conflicts of Interest DOB received consulting fees from MSD and payments for lectures including payments for serving on speaker bureaus from Lilly, Novo Nordisk, and Sanofi Pasteur. CM received fees for participation in review activities such as data monitoring boards, statistical analysis, and end point committees through his institution, Hospital Universitario Virgen Macarena. KFC, MV, CH, CAO, AGG, MC, and GF are full-time employees at MSD Spain. SAM, CB, SC, CG, OB, and AA have no potential conflicts of interest. Multimedia Appendix 1 Supplementary information. [DOCX File , 484 KB-Multimedia Appendix 1] References 1. International Diabetes Federation. IDF diabetes atlas—10th edition. Brussels: International Diabetes Federation; 2021. 2. Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Bäck M, ESC National Cardiac Societies, ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2021 Sep;42(34):3227-3337. 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[doi: 10.1016/j.dsx.2016.03.015] [Medline: 27055354] Abbreviations DTSQs: Diabetes Treatment Satisfaction Questionnaire status HbA : hemoglobin A 1c 1c HDL: high-density lipoprotein IEXPAC: Instrumento de Evaluación de la Experiencia del Paciente Crónico IPAQ: International Physical Activity Questionnaire LDL: low-density lipoprotein MARS-5: Medication Adherence Report Scale T2DM: type 2 diabetes mellitus Edited by A Sharma; submitted 28.06.22; peer-reviewed by S Sarejloo; comments to author 17.07.22; revised version received 21.07.22; accepted 18.08.22; published 03.10.22 Please cite as: Orozco-Beltrán D, Morales C, Artola-Menéndez S, Brotons C, Carrascosa S, González C, Baro Ó, Aliaga A, Ferreira de Campos K, Villarejo M, Hurtado C, Álvarez-Ortega C, Gómez-García A, Cedenilla M, Fernández G Effects of a Digital Patient Empowerment and Communication Tool on Metabolic Control in People With Type 2 Diabetes: The DeMpower Multicenter Ambispective Study JMIR Diabetes 2022;7(4):e40377 URL: https://diabetes.jmir.org/2022/4/e40377 doi: 10.2196/40377 PMID: ©Domingo Orozco-Beltrán, Cristóbal Morales, Sara Artola-Menéndez, Carlos Brotons, Sara Carrascosa, Cintia González, Óscar Baro, Alberto Aliaga, Karine Ferreira de Campos, María Villarejo, Carlos Hurtado, Carolina Álvarez-Ortega, Antón Gómez-García, Marta Cedenilla, Gonzalo Fernández. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 03.10.2022. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Diabetes, is properly cited. The complete bibliographic information, a link to the original publication on https://diabetes.jmir.org/, as well as this copyright and license information must be included. https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 13 (page number not for citation purposes) XSL FO RenderX http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JMIR Diabetes JMIR Publications

Effects of a Digital Patient Empowerment and Communication Tool on Metabolic Control in People With Type 2 Diabetes: The DeMpower Multicenter Ambispective Study

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Abstract

Background: Diabetes is a major health care problem, reaching epidemic numbers worldwide. Reducing hemoglobin A 1c (HbA ) levels to recommended targets is associated with a marked decrease in the risk of type 2 diabetes mellitus (T2DM)–related 1c complications. The implementation of new technologies, particularly telemedicine, may be helpful to facilitate self-care and empower people with T2DM, leading to improved metabolic control of the disease. Objective: This study aimed to analyze the effect of a home digital patient empowerment and communication tool (DeMpower App) on metabolic control in people with inadequately controlled T2DM. Methods: The DeMpower study was multicenter with a retrospective (observational: 52 weeks of follow-up) and prospective (interventional: 52 weeks of follow-up) design that included people with T2DM, aged ≥18 and ≤80 years, with HbA levels 1c ≥7.5% to ≤9.5%, receiving treatment with noninsulin antihyperglycemic agents, and able to use a smartphone app. Individuals were randomly assigned (2:1) to the DeMpower app–empowered group or control group. We describe the effect of empowerment on the proportion of patients achieving the study glycemic target, defined as HbA ≤7.5% with a ≥0.5% reduction in HbA at 1c 1c week 24. Results: Due to the COVID-19 pandemic, the study was stopped prematurely, and 50 patients (33 in the DeMpower app–empowered group and 17 in the control group) were analyzed. There was a trend toward a higher proportion of patients achieving the study glycemic target (46% vs 18%; P=.07) in the DeMpower app group that was statistically significant when the target was HbA ≤7.5% (64% vs 24%; P=.02) or HbA ≤8% (85% vs 53%; P=.02). The mean HbA was significantly reduced 1c 1c 1c https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al at week 24 (−0.81, SD 0.89 vs −0.15, SD 1.03; P=.03); trends for improvement in other cardiovascular risk factors, medication adherence, and satisfaction were observed. Conclusions: The results suggest that patient empowerment through home digital tools has a potential effect on metabolic control, which might be even more relevant during the COVID-19 pandemic and in a digital health scenario. (JMIR Diabetes 2022;7(4):e40377) doi: 10.2196/40377 KEYWORDS empowerment; home digital tool; telemedicine; type 2 diabetes; diabetic; home based; home care; self-management; digital tool; metabolic; HbA; glycated hemoglobin; glycemic control; adherence; satisfaction; observational study; health app shown that the use of telemedicine is associated with Introduction improvements in patients’ outcomes such as adherence, pathology control, and engagement [21,23-27]. However, in Diabetes is a major health care problem, reaching epidemic Spain, there are few studies evaluating eHealth solutions for numbers worldwide [1,2]. Globally, approximately 537 million people with T2DM, mostly developed in small local settings people had type 2 diabetes mellitus (T2DM) in 2021, but it is [28-33]. expected that these numbers will increase up to nearly 783 million people by 2045 due to aging populations and the Taking into account the high prevalence and burden of T2DM negative impact of some lifestyles, such as obesity and in Spain and the current high number of people with inadequate sedentarism [1-3]. This translates into a huge socioeconomic metabolic control, developing innovative solutions to improve impact in addition to the health care burden [4]. In Spain, the this situation is necessary. This improvement should be made prevalence of T2DM is estimated to be approximately 14% [5], through patient empowerment by increasing self-management and the direct health costs of diabetes account for approximately and communication between patients and health care 8% of total public health expenditures [6]. professionals, allowing more effective T2DM control. Reducing hemoglobin A (HbA ) levels to recommended 1c 1c The aim of this study was to analyze the effect of a home digital targets is associated with a marked decrease in the risk of patient empowerment and communication tool (DeMpower T2DM-related complications [7]. Although adopting a healthy App) on metabolic control in people with T2DM and inadequate lifestyle (diet and physical activity) is necessary in T2DM to HbA levels compared to a control group, both treated 1c improve metabolic control, most people with T2DM will need according to usual clinical practice. at least 1 antidiabetic agent to control blood glucose levels. The pharmacological options to treat hyperglycemia in T2DM have Methods improved substantially over the past 20 years with the development of new therapeutic agents that not only safely Overview reduce HbA levels but also have cardiovascular and renal 1c The DeMpower study was a multicenter and an ambispective benefits; unfortunately, many people with T2DM do not achieve study including adults with T2DM having inadequate glycemic recommended HbA targets (<7%) [8,9]. In Spain, the 1c control, treated according to clinical practice across Spain. The proportion of people with T2DM with good glycemic control study population included people with T2DM aged ≥18 and has not improved markedly over the last decade, remaining at ≤80 years from Spanish health care sites with HbA levels 1c around 50%-60%, suggesting that additional approaches are ≥7.5% and ≤9.5%, who were receiving treatment with noninsulin warranted [10-12]. Moreover, the lockdown during the antihyperglycemic agents and who were able to use a COVID-19 pandemic has led to a worsening of follow-up and smartphone-based home digital tool. The main exclusion criteria metabolic control in people with T2DM globally and in Spain were the use of insulin treatments, pregnancy, any scheduled [13-16]. surgery, terminal or severe diseases, or any medical or psychological condition that, in the investigator’s opinion, might Although many causes have emerged to explain this poor have compromised the ability of the patient to provide informed metabolic control in people with T2DM, poor adherence to consent. Patients were recruited consecutively as they visited treatment and clinical inertia play a key role [17-19]. Therefore, the doctor’s office, reducing the possibility of selection bias proper management of T2DM is challenging and deserves and strengthening the generalizability of the results. constant attention and comprehensive patient-centered clinical assistance. Consequently, it is necessary to transform health The enrollment period was approximately 12 months and care systems to provide integrated and patient-centered chronic patients were followed up for 52 weeks. The primary end point care models [20]. was assessed at week 24 of follow-up. Retrospective data were collected during the 52 weeks prior to the baseline visit, and In this context, the implementation of new technologies, the HbA determination closest to the 24 weeks before baseline 1c particularly telemedicine, may be helpful to facilitate patient and the antidiabetic treatment prescribed at that time were self-care and empowerment [21,22]. In fact, effective diabetes recorded. After the enrollment period, patients were randomly self-management is a key goal, but it should be measured and assigned (2:1) to two comparative groups: group 1 (DeMpower monitored as part of routine care and technology may help app–empowered group), where patients were clinically managed patients and guide clinical decisions [22]. Different studies have https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al according to usual clinical practice and used the DeMpower satisfaction with the DeMpower app and experience with health app during the prospective study follow-up, and group 2 (control care received were also assessed. Finally, the mean number of group), where patients were clinically managed according to symptomatic and asymptomatic hypoglycemic events (≤70 usual clinical practice without the DeMpower app. After the mg/dL) registered at emergency departments from baseline to primary assessment at week 24, patients in group 1 were week 24 between groups 1 and 2 was determined. randomized again (1:1) to assess the durability of the effect at Questionnaires were used to evaluate study outcomes related week 52: group 1a (DeMpower app–empowered group, to the degree of physical activity (International Physical Activity long-term use), where patients kept using the DeMpower app, Questionnaire [IPAQ]), patient adherence to treatment and group 1b (DeMpower app–empowered group, short-term (Medication Adherence Report Scale [MARS-5]), satisfaction use), where patients stopped using the DeMpower app. Both with the DeMpower app (Diabetes Treatment Satisfaction groups continued being clinically managed according to usual Questionnaire status [DTSQs] version), and experience with clinical practice (Figure S1 in Multimedia Appendix 1). The health care received (Instrumento de Evaluación de la follow-up of group 2 continued without changes. eXperiencia del PAciente Crónico [IEXPAC]) [19,34-37]. In In group 1, patients received the following commercially this study, the short-form IPAQ was used, consisting of 4 available devices to use in combination with and connected to generic domains with 7 questions in total for use in either the DeMpower app: scale, glucometer, blood pressure monitor, interviews or self-administered methods [34]. The MARS-5 is and activity wristband. Patients were also trained to use the a 5-item scale that includes questions about the way patients devices according to routine clinical practice, as agreed with take their medicines and whether they forget to take them. their health care professionals (ie, taking periodic measurements Patients report agreement with statements about medicines using of their glucose and blood pressure levels as well as their weight a 5-point Likert scale (from “always” [scored as 1] to “never” and degree of physical activity). Data from these devices (body [scored as 5]). The maximum total score for all questions weight, glucose levels, blood pressure, and number of steps answered as “never” is 25 [35]. The DTSQs is an 8-item taken daily) were received wirelessly by the DeMpower app questionnaire, with 6 questions assessing treatment satisfaction for each patient and sent to the corresponding health care team and the other 2 assessing the perceived frequency of to review the patient’s activity and measurements, answer patient hyperglycemia and hypoglycemia. Each item is scored from 6 questions, and contact the patient, when needed (Figure S2 in (ie, very satisfied) to 0 (ie, very dissatisfied), with the treatment Multimedia Appendix 1). However, this channel of direct satisfaction scale ranging from 36 (ie, very satisfied) to 0 (ie, communication did not substitute clinical practice, and if health very dissatisfied) and the perceived frequency of hyperglycemia care was required due to an emergency, patients followed the and hypoglycemia scores ranging from 6 (ie, most of the time) usual procedure of going to the emergency department of to 0 (ie, none of the time) [36]. The IEXPAC is a 12-item scale primary care centers or hospitals. that includes 11 questions plus 1 more conditional question about the experience of patients with chronic conditions Patients in both groups received the same routine care and did regarding the health care and social attention that they have not undergo any interventions, whether diagnostic or monitoring, received. Items are answered as never (0 points), seldom (2.5 other than those planned according to routine clinical practice. points), sometimes (5 points), most times (7.5 points), and Clinical data and antidiabetic treatment details were collected always (10 points). The overall score of the 11 questions is from the clinical history of patients and from information calculated as their average score and ranges from 0 to 10. The provided by the patient during the study visit and entered into additional question (item 12) is reported separately and ranges the electronic case report form. Laboratory parameters, including from 0 to 10 [19,37]. HbA , low-density lipoprotein (LDL) cholesterol, and 1c Assuming a bilateral contrast, an alpha risk of .05, a power of high-density lipoprotein (HDL) cholesterol, were taken from 80%, a proportion of response of 50% for each group and a blood samples of all patients collected at baseline and thereafter, patient loss of ≤13%, 100 patients were needed in group 1 following local clinical practice until study completion or early (DeMpower app–empowered patients) and 50 patients in group study discontinuation. 2 (control group) to detect a difference equal to or higher than The main evaluations compared groups 1 and 2 at week 24. The 25% between both groups with regard to the primary study primary outcome of the study was to evaluate whether objective. For the descriptive analysis, quantitative variables empowerment would reduce the proportion of patients persisting were described with measures of centralization and dispersion without metabolic control at week 24. The primary study (mean and SD), whereas qualitative variables were described glycemic target was an HbA level ≤7.5% with a reduction in 1c by their absolute (N) and relative (%) frequencies. To compare HbA of ≥0.5% at week 24. Other secondary predefined study 1c 2 means between groups, parametric (Student t test) and glycemic targets were HbA ≤8%, HbA ≤7%, and nonparametric (Mann-Whitney U test) tests were used, as 1c 1c individualized HbA targets for each patient at week 24, as required. Categorical variables were compared with the 1c chi-square or the Fisher exact test, when appropriate. Hypothesis established by the investigators. The absolute HbA change at 1c tests were 2-tailed in all cases, with a significance level of .05. week 24 versus baseline was also a predefined secondary end The evolution of HbA throughout treatment was evaluated 1c point. In addition, mean changes in the body weight, BMI, blood using a general linear model of repeated measures. Absences pressure, LDL and HDL cholesterol levels, physical activity of data were not accounted for and were considered missing (measured as metabolic equivalent of task in min/week), and patient adherence to treatment were measured. Patient https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al data. Statistical analyses were performed using SPSS (version of patients using the DeMpower app, could have been affected 22.0 or higher; IBM Corp). by the generally altered lifestyles of the patients during and after the COVID-19 lockdown period, both in the empowered Ethics Approval and control groups. At the time of study discontinuation, 98 The study was approved by the following ethics committees: patients had been recruited in 15 of the 25 participating sites Institut Universitari d’Investigació en Atenció Primària Jordi across Spain. Among these, 9 patients were excluded, as they Gol (reference 5OB18/010), General University Hospital of did not meet the selection criteria and 89 were evaluable. Many Elda, Central Research Commission of Madrid, Murcian Health of the patients were not able to attend visits and procedures due Service, and Health Areas of León and Bierzo. to the lockdown, and finally, 50 patients (33 patients in group 1 and 17 patients in group 2) completed the study visit at week Results 24 and were considered valid for the final analysis of the main study end points. At week 52, the number of patients remaining Due to the COVID-19 pandemic, the study was stopped in groups 1a, 1b, and 2 were 6, 5, and 6, respectively (Figure prematurely (July 2020), with a relevant impact on both the 1). No patients abandoned the study due to an inability to adapt recruitment and follow-up of patients. In addition, the primary to the DeMpower app. hypothesis of the study, which was based on the empowerment Figure 1. Study flowchart. HbA : hemoglobin A ; IC: informed consent; T2DM: type 2 diabetes mellitus. 1c 1c The baseline clinical characteristics of the study population are cardiovascular disease being the most common (61% vs 47%, shown in Table 1. The groups were well balanced, without respectively; P=.39). At baseline, the mean (SD) HbA values 1c statistically significant between-group differences regarding were 8.2 (0.5) and 8.3 (0.6), respectively (P=.57). The most clinical characteristics or baseline treatments, except for the commonly prescribed antidiabetic drugs were metformin (88% presence of transient ischemic attack (no patients in group 1 vs vs 100%, respectively; P=.29), dipeptidyl peptidase-4 inhibitors 3 patients in group 2, P=.04) and the use of glinides (0 patients (61% vs 41%; P=.24), sodium-glucose cotransporter-2 inhibitors in group 1 vs 3 patients in group 2, P=.03). The mean age of (42% vs 53%; P=.56), and sulphonylureas (46% vs 18%; P=.40). the patients was 64 (SD 8) years, with 25% (13/50) older than Regarding the primary metabolic objective, there was a trend 69 years, and 50% (25/50) of all patients were aged between toward a higher proportion of people with T2DM achieving 59 and 69 years. Overall, 66% (33/50) were male and 96% HbA levels ≤7.5% with a reduction of ≥0.5% in HbA with 1c 1c (48/50) were Caucasian; the mean diabetes duration was 10 (SD 2 respect to the baseline value at week 24 (primary outcome) in 6) years, and the mean BMI was 29.7 (SD 4.9) kg/m . group 1 compared with that in group 2 (46% vs 18%; P=.07), Complications associated with diabetes were not observed in and this reached statistical significance when considering the 70% (23/33) of the patients in group 1 and 71% (12/17) of the proportion of people with T2DM achieving HbA levels ≤7.5% 1c patients in group 2 (P>.99). The majority of patients had at least at week 24 (64% vs 24%, respectively; P=.02; Figure 2). 1 comorbidity (70% vs 59%, respectively; P=.53), with https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al When analyzing the percentage of patients with HbA levels groups at week 24. In both groups, there was an overall increase 1c in the prescription of antidiabetic agents at week 24 (Table S1 ≤7% at week 24 (36% vs 12%, respectively; P=.1) or the in Multimedia Appendix 1). proportion of patients controlled according to the individualized HbA objectives for each patient established by the investigators 1c The evolution of the BMI, systolic blood pressure, diastolic (67% vs 82%, respectively; P=.33), no significant blood pressure, LDL, HDL, and physical activity from the between-group differences were observed. However, more baseline visit to week 24 is shown in Table S2 in Multimedia patients in group 1 achieved significant HbA levels ≤8% at 1c Appendix 1. Although no statistically significant between-group week 24 (85% vs 53%, respectively; P=.02; Figure 3). differences were observed, there was a positive trend for group 1, with relevant reductions in the BMI and blood pressure, and HbA levels from baseline to week 24 significantly decreased 1c an increase in physical activity. to a higher extent in group 1 versus group 2 (−0.81 [0.89] vs −0.15 [1.03]; mean difference −0.66%; P=.03). This statistically The MARS-5 responses showed similar adherence to treatment significant difference remained after adjusting for changes in in both groups at week 24, but with a positive trend in group 1. antidiabetic treatment, age, sex, duration of diabetes, smoking Patient satisfaction (DTSQs) and experience with the health status, socioeconomic status, educational level, and employment care system (IEXPAC) were positive in both groups, with no situation (Figure 4). significant between-group differences (Table S3 in Multimedia Appendix 1). No symptomatic and asymptomatic hypoglycemic events (≤70 mg/dL) from baseline to week 24 were reported in any of the Due to the small number of patients completing the week 52 groups at emergency departments both from primary care centers visit (17/50, 34%), no analysis was performed for the study and hospitals. With regard to antidiabetic drugs, there were no exploratory end points at this time. statistically significant differences in treatment between the https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Table 1. Baseline sociodemographic characteristics of patients completing 24 weeks of follow-up. Characteristic Group 1 (n=33) Group 2 (n=17) P value Age (years), mean (SD) 63.3 (6.4) 64.4 (9.5) .46 Sex (male), n (%) 22 (66.7) 11 (64.7) >.99 Race, n (%) >.99 Caucasian 32 (97) 16 (94.1) Other 1 (3.0) 1 (5.9) Educational level, n (%) .32 Primary 10 (30.3) 8 (47.1) Secondary 14 (42.4) 3 (17.6) Higher education 8 (24.2) 5 (29.4) Unknown 1 (3.0) 1 (5.9) Professional situation, n (%) .94 Unemployed 2 (6.1) 1 (5.9) Employee 9 (27.3) 4 (23.5) Autonomous 3 (9.1) 2 (11.8) Retired 17 (51.5) 8 (47.1) Other 2 (6.1) 2 (11.8) Lifestyle habits, n (%) .06 Active smoker 8 (24.2) 0 (0.0) Ex-smoker 15 (45.5) 8 (47.1) Never been a smoker 10 (30.3) 9 (52.9) Unknown 0 (0.0) 0 (0.0) 10.3 (7.3) 10.6 (4.6) .47 Time from T2DM diagnosis to study inclusion (years), mean (SD) Complications associated with T2DM disease, n (%) None 23 (69.7) 12 (70.6) >.99 Microalbuminuria 6 (18.2) 1 (5.9) .40 Peripheral vascular disease 3 (9.1) 1 (5.9) >.99 Ischemic heart disease 2 (6.1) 1 (5.9) >.99 Neuropathy 2 (6.1) 2 (11.8) .60 Stroke 1 (3.0) 3 (17.6) .11 Retinopathy 1 (3.0) 1 (5.9) >.99 Transient ischemic attack 0 (0.0) 3 (17.6) Heart failure 1 (3.0) 0 (0.0) >.99 Other complications 2 (6.1) 1 (5.9) >.99 ≥1 comorbidity, n (%) 23 (69.7) 10 (58.8) .53 Cardiovascular disease 20 (60.6) 8 (47.1) .39 Musculoskeletal disorder 10 (30.3) 5 (29.4) >.99 Endocrine disorder 7 (21.2) 3 (17.6) >.99 Neurological/psychiatric disorder 5 (15.2) 4 (23.5) .47 Gastrointestinal disorder 3 (9.1) 2 (11.8) >.99 Respiratory disease 5 (15.2) 2 (11.8) >.99 Hematological disease 4 (12.1) 0 (0.0) .29 https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Characteristic Group 1 (n=33) Group 2 (n=17) P value Renal disease 2 (6.1) 1 (5.9) >.99 Infectious disease 2 (6.1) 1 (5.9) >.99 Cancer 2 (6.1) 2 (11.8) .60 Autoimmune disease 1 (3.0) 0 (0.0) >.99 Physical examination, mean (SD) 30.2 (5.3) 28.7 (4.1) .40 BMI (Kg/m ) 137 (16.6) 130 (15.8) .26 SBP (mmHg) 79.5 (9.5) 76.1 (7.5) .08 DBP (mmHg) Laboratory parameters, mean (SD) 8.2 (0.5) 8.3 (0.6) .57 HbA (mg/dL) 1c Glucose 173.0 (35.3) 171.0 (38.9) .84 47.6 (18.1) 47.4 (11.2) .58 HDL cholesterol (mg/dL) 96.9 (29.7) 98.5 (34.6) .85 LDL cholesterol (mg/dL) Individualized HbA target 7.0 (0.2) 7.2 (0.3) .05 1c HbA (mg/dL), value closest to week 24 7.9 (0.9) 8.2 (1.0) .56 1c Antidiabetic drugs , n (%) Metformin 29 (87.9) 16 (94.1) .49 19 (57.6) 8 (47.1) .48 DPP-4 inhibitors 11 (33.3) 8 (47.1) .34 SGLT2 inhibitors Sulfonylurea 14 (42.4) 3 (17.6) .08 3 (9.1) 1 (5.9) .69 GLP1 receptor agonists Glinides 0 (0.0) 3 (17.6) .03 Glitazones 1 (3) 0 (0.0) .98 T2DM: type 2 diabetes mellitus. Italics indicate significant P values <.05. SBP: systolic blood pressure. DBP: diastolic blood pressure. HbA : hemoglobin A . 1c 1c HDL: high-density lipoprotein. LDL: Low-density lipoprotein. Patients may have been indicated as receiving more than one antidiabetic drug. DPP-4: dipeptidyl peptidase-4. SGLT2: sodium-glucose cotransporter-2. GLP1: glucagon-like peptide-1. https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Figure 2. Primary composite outcome and individual components. Primary composite outcome refers to the proportion of patients achieving the study glycemic target (HbA ≤7.5% with a reduction in HbA ≥0.5% with respect to baseline value) at week 24. HbA : hemoglobin A1c. 1c 1c 1c Figure 3. Proportion of patients with HbA ≤7%, HbA ≤8%, and individualized HbA target established by the investigator at week 24. HbA : 1c 1c 1c 1c hemoglobin A . 1c https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 8 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al Figure 4. Changes in HbA from baseline to week 24. HbA : hemoglobin A . *Least square means with adjustments for changes in antidiabetic 1c 1c 1c treatment, age, sex, duration of diabetes, smoking status, socioeconomic status, educational level, and employment situation. significant for secondary outcomes such as HbA levels ≤7.5% 1c Discussion and ≤8% at week 24, as well as absolute HbA reduction at 1c week 24, even after adjusting for several clinical characteristics The results from this study suggest that patient empowerment including treatment modification. In particular, the 0.66% using the DeMpower app might improve metabolic control in difference in HbA levels between groups is clinically relevant people with T2DM who do not achieve HbA targets with the 1c 1c standard care, possibly leading to a more efficient management and was achieved without increasing the risk of hypoglycemia. of the disease. This is particularly remarkable given that there were no differences regarding the use or modification of antidiabetic The COVID-19 pandemic lockdown had a direct impact on the drugs between both groups. These results support the clinical recruitment and follow-up of patients, reducing the planned utility of the DeMpower app as a home digital patient study size. In addition, during lockdown, patients were not able empowerment and communication tool that might help patients to practice outdoor physical activities; some patients might have achieve glycemic control that is independent of the antidiabetic had uncontrolled dietary habits and physical access to health treatment. Similarly, previous studies have also shown the care providers was limited, leading to impaired metabolic control benefits of home-based digital patient empowerment tools in in both groups. Additionally, this could have also impacted the control of T2DM [23-33,43-47]. For example, the ValCrónic patient-reported outcomes (ie, physical activity, adherence, as study [30] showed that the proportion of people with HbA ≥8% 1c well as satisfaction and experience questionnaires). In fact, decreased significantly (by 44%) after 1 year of telemonitoring. many research projects unrelated to COVID-19 have been In our study, 85% of patients using the digital tool achieved substantialy reduced or even suspended due to legal restrictions HbA ≤8%, compared to 53% in the control group (absolute 1c or logistical, staffing, or operational concerns worldwide, as difference 32%; relative difference 60%; P=.02). Additionally, well as because of lockdowns or restrictions. Thus, a more meta-analyses of randomized controlled trials on telemedicine flexible approach that ensures participant safety is warranted interventions have confirmed significant improvements in the during the COVID-19 pandemic, under the good clinical practice management of diabetes compared with standard care [44,45]. umbrella [38]. In this context, investigating the impact of The use of home digital tools for people with T2DM telemonitoring and telemedicine in patients with chronic empowerment and metabolic control has become even more conditions such as T2DM should be considered a priority, as it important during the COVID-19 pandemic, as during this period, may facilitate better disease control [39,40]. metabolic control among people with T2DM has worsened The study groups were well balanced. The majority of patients [13-16]. In contrast, glycemic values in people with type 1 were aged >60 years, had at least 1 comorbidity, and were taking diabetes significantly improved during the COVID-19 lockdown, more than 1 antidiabetic drug. This is in line with the clinical which may be associated with positive changes in self-care and profiles reported in other studies of people with T2DM digital diabetes management [16]. This reinforces the importance [10,41,42], indicating that patients included in our study were of improving self-care management using digital tools in T2DM likely to be representative of the Spanish population with T2DM. and is in line with the DeMpower study results, suggesting that eHealth and telemedicine could reduce the negative impact of In our study, there was a trend in the primary outcome with a the COVID-19 pandemic and might be relevant in the digital higher numerical proportion of empowered patients achieving health framework. the study glycemic target at week 24 compared to those in the control group. The between-group differences were statistically https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 9 (page number not for citation purposes) XSL FO RenderX JMIR DIABETES Orozco-Beltrán et al People with T2DM often present other comorbidities such as significant differences. Similar results have been previously hypertension, dyslipidemia, obesity, and renal or cardiovascular obtained regarding the information that patients receive or can disease [41,42]. Consequently, to reduce the cardiovascular access [19,37]. burden in T2DM, it is necessary to implement a comprehensive This study has some limitations. As noted earlier, the most approach that includes not only glycemic control but also blood relevant limitation is that the COVID-19 pandemic led to a pressure, lipid profile, body weight, and physical activity [48]. premature study termination, and consequently, the estimated In our study, there was a positive trend for some of these sample size of 150 patients could not be achieved. This might variables in patients who used the DeMpower app. Additionally, have impacted the statistical power for the assessment of the considering that the lockdown during COVID-19 had a negative main study outcome. As this study was designed to collect impact on metabolic and weight control [13-16], it is likely that information available in routine clinical practice at the with a larger sample size, these differences would have reached participating sites, some data were unavailable, limiting the statistical significance. Besides, a recent meta-analysis of 43 validity of the study results. Likewise, the appearance of bias studies reported a positive impact of telemedicine not only on derived from the unsuccessful use of digital tools could not be HbA but also on diastolic blood pressure, weight, and mental 1c ruled out, but this was expected to be minimized by the selection and physical quality of life, among people with T2DM [45]. of patients with a proven ability to use home mobile apps on Moreover, in the IDIATel randomized controlled trial [49] that their smartphones. compared telemedicine case management to routine care, greater In summary, the DeMpower study results strongly suggest that reductions in LDL cholesterol and systolic and diastolic blood patient empowerment through a home digital tool might lead pressure levels were achieved with telemedicine. to more effective metabolic control and consequently to more Patient satisfaction with treatment is important to improve effective achievement of the clinical objectives in people with medication adherence [50]. Although our study did not show T2DM. This study reinforces the importance of using significant differences between groups, previous studies have telemedicine and new technologies for patient empowerment shown an improvement with telemedicine [45]. Finally, the and metabolic control, especially in the digital health scenario. experience of patients regarding the health care attention Moreover, these findings appear to be crucial during situations received, evaluated with the IEXPAC tool, showed that there with limited patient access to health care and negative health was opportunity for improvement for both groups, without consequences, such as the COVID-19 pandemic. Acknowledgments The Spanish Diabetes Federation provided study endorsement and advice for the app design. Writing assistance was provided by Content Ed Net. This study was funded and sponsored by Merck Sharp & Dohme de España S.A (MSD Spain), a subsidiary of Merck & Co, Inc, Rahway, NJ. Conflicts of Interest DOB received consulting fees from MSD and payments for lectures including payments for serving on speaker bureaus from Lilly, Novo Nordisk, and Sanofi Pasteur. CM received fees for participation in review activities such as data monitoring boards, statistical analysis, and end point committees through his institution, Hospital Universitario Virgen Macarena. KFC, MV, CH, CAO, AGG, MC, and GF are full-time employees at MSD Spain. SAM, CB, SC, CG, OB, and AA have no potential conflicts of interest. Multimedia Appendix 1 Supplementary information. [DOCX File , 484 KB-Multimedia Appendix 1] References 1. International Diabetes Federation. IDF diabetes atlas—10th edition. Brussels: International Diabetes Federation; 2021. 2. Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Bäck M, ESC National Cardiac Societies, ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2021 Sep;42(34):3227-3337. 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[doi: 10.1016/j.dsx.2016.03.015] [Medline: 27055354] Abbreviations DTSQs: Diabetes Treatment Satisfaction Questionnaire status HbA : hemoglobin A 1c 1c HDL: high-density lipoprotein IEXPAC: Instrumento de Evaluación de la Experiencia del Paciente Crónico IPAQ: International Physical Activity Questionnaire LDL: low-density lipoprotein MARS-5: Medication Adherence Report Scale T2DM: type 2 diabetes mellitus Edited by A Sharma; submitted 28.06.22; peer-reviewed by S Sarejloo; comments to author 17.07.22; revised version received 21.07.22; accepted 18.08.22; published 03.10.22 Please cite as: Orozco-Beltrán D, Morales C, Artola-Menéndez S, Brotons C, Carrascosa S, González C, Baro Ó, Aliaga A, Ferreira de Campos K, Villarejo M, Hurtado C, Álvarez-Ortega C, Gómez-García A, Cedenilla M, Fernández G Effects of a Digital Patient Empowerment and Communication Tool on Metabolic Control in People With Type 2 Diabetes: The DeMpower Multicenter Ambispective Study JMIR Diabetes 2022;7(4):e40377 URL: https://diabetes.jmir.org/2022/4/e40377 doi: 10.2196/40377 PMID: ©Domingo Orozco-Beltrán, Cristóbal Morales, Sara Artola-Menéndez, Carlos Brotons, Sara Carrascosa, Cintia González, Óscar Baro, Alberto Aliaga, Karine Ferreira de Campos, María Villarejo, Carlos Hurtado, Carolina Álvarez-Ortega, Antón Gómez-García, Marta Cedenilla, Gonzalo Fernández. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 03.10.2022. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Diabetes, is properly cited. The complete bibliographic information, a link to the original publication on https://diabetes.jmir.org/, as well as this copyright and license information must be included. https://diabetes.jmir.org/2022/4/e40377 JMIR Diabetes 2022 | vol. 7 | iss. 4 | e40377 | p. 13 (page number not for citation purposes) XSL FO RenderX

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JMIR Diabetes – JMIR Publications

Published: Oct 3, 2022

Keywords: empowerment; home digital tool; telemedicine; type 2 diabetes; diabetic; home based; home care; self-management; digital tool; metabolic; HbA; glycated hemoglobin; glycemic control; adherence; satisfaction; observational study; health app

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