Effectiveness of a Digital Health Application for the Treatment of Diabetes Type II-A Pilot Study.

(1) Background: This study aimed at providing preliminary evidence for mebix, an app-based treatment program for patients with diabetes mellitus type II. The main target was to show a positive healthcare impact as defined by improved blood glucose control, i.e., reduced HbA1c values. (2) Methods: For this, a 3-month, prospective, open-label trial with an intraindividual control group was conducted. Participants received the mebix intervention for 3 months. HbA1c values were observed every 3 months: retrospectively, at baseline, and 3 months after the start of using the app. Additionally, weight and patients' reported outcomes (well-being, diabetes-related distress, and self-management) were assessed. Data generated within the app were summarized and analyzed (steps, physical activity, fulfilled tasks, and food logs). (3) Results: After the usage of mebix for 3 months, participants significantly reduced their HbA1c levels (-1.0 ± 0.8%). Moreover, improvements in weight, well-being, and self-management as well as a reduction in diabetes-related distress were observed. App-generated data mainly supported the other main finding, that higher baseline HbA1c values lead to higher reductions. Overall, the study provided preliminary evidence that mebix can help patients improve metabolic and psychological health outcomes.

Genome-wide association study and functional characterization identifies candidate genes for insulin-stimulated glucose uptake.

Distinct tissue-specific mechanisms mediate insulin action in fasting and postprandial states. Previous genetic studies have largely focused on insulin resistance in the fasting state, where hepatic insulin action dominates. Here we studied genetic variants influencing insulin levels measured 2 h after a glucose challenge in >55,000 participants from three ancestry groups. We identified ten new loci (P < 5 × 10-8) not previously associated with postchallenge insulin resistance, eight of which were shown to share their genetic architecture with type 2 diabetes in colocalization analyses. We investigated candidate genes at a subset of associated loci in cultured cells and identified nine candidate genes newly implicated in the expression or trafficking of GLUT4, the key glucose transporter in postprandial glucose uptake in muscle and fat. By focusing on postprandial insulin resistance, we highlighted the mechanisms of action at type 2 diabetes loci that are not adequately captured by studies of fasting glycemic traits.

Design of the DAVOS Study: Diabetes Smartphone App, a Fully Automatic Transmission of Data From the Blood Glucose Meter and Insulin Pens Using Wireless Technology to Enhance Diabetes Self-Management-A Study Protocol for a Randomized Controlled Trial.

BACKGROUND: In the treatment of diabetes mellitus, the challenge is to integrate adequate self-management into clinical care. Customization including goal setting, monitoring, and feedback could be achieved through digitization. Digital linking between different devices could simplify and promote self-management. The aim of this study is to evaluate the outcome of diabetes treatment assisted by a digital health application compared with standard diabetes therapy. METHODS: The DAVOS study is a 6-month-period prospective, multicentric, randomized controlled trial. In total, 154 diabetes patients (age ≥18; treated with insulin) will be recruited and randomized into control group or intervention group. Both groups will receive standard diabetes care. The intervention group will additionally use a diabetes app. HbA1c value will be monitored on three separate defined visits. Primary endpoint is the overall reduction of HbA1c value. Secondary endpoints (eg, usability of the app) will be determined through patient-reported outcome questionnaires. DISCUSSION: Through enhanced interaction of health care professionals, providers of the app, and patients, the study aims to demonstrate improvement in the self-management of diabetes. As part of the closure management, all patients will be invited to use the examined application after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization-Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.

Comparing Digital Therapeutic Intervention with an Intensive Obesity Management Program: Randomized Controlled Trial.

In this study, we evaluated whether the digital program Vitadio achieves comparable results to those of an intensive in-person lifestyle intervention in obesity management. This is a 12-month prospective, randomized controlled trial. Obese patients with insulin resistance, prediabetes or type 2 diabetes were included. The intervention group (IG) used Vitadio. The control group (CG) received a series of in-person consultations. Body weight and various metabolic parameters were observed and analyzed with ANOVA. The trial is ongoing and the presented findings are preliminary. Among 100 participants (29% men; mean age, 43 years; mean BMI, 40.1 kg/m2), 78 completed 3-month follow-up, and 51 have completed the 6-month follow-up so far. Participants significantly (p < 0.01) reduced body weight at 3 months (IG: −5.9 ± 5.0%; CG: −4.2 ± 5.0%) and 6 months (IG: −6.6±6.1%; CG: −7.1 ± 7.1%), and the difference between groups was not significant. The IG achieved favorable change in body composition; significant improvement in TAG (−0.6 ± 0.9 mmol/l, p < 0.01), HDL (0.1 ± 0.1%, p < 0.05), HbA1c (−0.2 ± 0.5%, p < 0.05) and FG (−0.5 ± 1.5 mmol/l, p < 0.05); and a superior (p = 0.02) HOMA-IR reduction (−2.5 ± 5.2, p < 0.01). The digital intervention achieved comparable results to those of the intensive obesity management program. The results suggest that Vitadio is an effective tool for supporting patients in obesity management and diabetes prevention.

Impact of a Digital Lifestyle Intervention on Diabetes Self-Management: A Pilot Study.

The aim of this study was to provide preliminary evidence on the impact of the digital health application Vitadio on improving glycemic control in patients with type 2 diabetes mellitus. This was a 3-month, prospective, multicenter, open-label trial with an intraindividual control group. Participants received a digital lifestyle intervention. HbA1c levels were observed at 3 time points: retrospectively, at 3 months before app use; at baseline, at the start of usage; and 3 months after the start of use. In addition, changes in other metabolic parameters (fasting glucose, body weight, and waist circumference), patient reported outcomes (quality of life, self-efficacy, and depression), and data generated within the app (frequency of use, steps, and photos of meals) were evaluated. Repeated measures analysis of variance with the Bonferroni correction was used to assess the overall difference in HbA1c values between the intervention and the intraindividual control group, with p < 0.05 considered significant. Participants (n = 42) were 57 ± 7.4 years old, 55% male, and with a mean baseline HbA1c of 7.9 ± 1.0%. An average HbA1c reduction of −0.9 ± 1.1% (p < 0.001) was achieved. The digital health application was effective in significantly reducing body weight (−4.3 ± 4.5 kg), body mass index (−1.4 ± 1.5 kg/m2), waist circumference (−5.7 ± 15 cm), and fasting glucose (−0.6 ± 1.3 mmol/L). The digital therapy achieved a clinically meaningful and significant HbA1c reduction as well as a positive effect on metabolic parameters. These results provide preliminary evidence that Vitadio may be effective in supporting patient diabetes management by motivating patients to adopt healthier lifestyles and improving their self-management.