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INTRODUCTION: The shortage of general practitioners (GPs) and the increasing prevalence of type 2 diabetes create significant pressure on primary healthcare services. To enable that medical services are available to all that need it, innovative solutions are needed. One of those, a Short Message Service (SMS)-supported basal insulin titration service is investigated in this study. The primary objective was to determine the percentage of subjects who achieved stable fasting blood glucose (FBG) within their individual target range with this service after week 16. METHODS: This single-arm, 16-week study aimed to enroll 111 adults diagnosed with type 2 diabetes that needed insulin. The study subjects measured their FBG 4 consecutive days to establish a baseline, then received SMS prompts for daily FBG measurements and evening insulin injections until their FBG stabilized within the target range. Adjusting the insulin based on the FBG. Once stabilization was achieved, subjects continued with their optimal insulin dose for the remainder of the study. Sixteen weeks after the baseline, subjects measured FBG for 4 days before visit 4, where these values were read by the healthcare provider. RESULTS: Out of the planned 111 subjects, only 30 were enrolled, with one withdrawal prior to service activation. Challenges in subject recruitment were attributed to the COVID-19 outbreak, limited eligibility, competing studies, and new medications delaying insulin initiation. Subjects were on average 59.97 years old, had an HbA1c of 9.29% a FBG of 205.64 mg/dl, and had diabetes for 10 years. Among the 29 subjects who started the service, 72% achieved successful titration at visit 4, with a median time of 49 days. Notable improvements were observed in HbA1c levels (decreased by 1.58%) and FBG levels (decreased by 64 mg/dl) over the 16-week study period. No adverse events or device-related issues were reported. CONCLUSIONS: Despite recruitment challenges, guided basal insulin titration holds promise for insulin therapy initiation in individuals. The findings emphasize the potential of tele-medical approaches, specifically through remote messaging, in managing diabetes and improving therapy adherence.
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BACKGROUND: Integrated personalized diabetes management (iPDM) is a digitally supported therapeutic concept to improve patient-physician interaction to overcome the aspects of clinical inertia. Integrated personalized diabetes management can support decision making and improve therapeutic outcomes of suboptimally controlled persons with insulin-treated type 2 diabetes (T2D). In this paper, we report the results of an analysis of the PDM-ProValue study program on the effectiveness and perceived benefit of this approach, with a focus on how physicians used and assessed the digital tools provided for the iPDM process. MATERIALS AND METHODS: The study program included two 12-month, prospective, controlled, cluster-randomized multicenter trials. A total of 101 practices participated with 907 patients. Practices were cluster-randomized to an intervention group and a control group. Digital tools for data visualization and analysis applied were used. HCP were asked to assess the use, relevance, and usefulness of the tools. RESULTS: A clear preference was stated for the visual overview over more statistically complex analyses. A total of 83% of the participants rated a high relevance of the "daily profile," 81% of the "total profile," and 68% the "risk illustrated by traffic light symbols" for the therapy decision. The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP). CONCLUSIONS: Embedding digital tools in a structured process (iPDM) were proved to provide a benefit for insulin-treated T2D patients and their physicians. These results offer insight for further development and improvement of the tools and add information on how to overcome clinical inertia.
