A decision support system (DSS) which included real-time dosing advice and retrospective therapy optimization, combined with continuous glucose monitoring (CGM), may be an option for glycemic control in patients with type 1 diabetes (T1D) using multiple daily injections (MDI). However, the full range of glycemic benefits system requires further exploration, according to researchers who published their study findings in Diabetes Care.
The 3-site research study included 80 adults and adolescents with T1D who used MDI to manage their condition. Participants randomly assigned to the control group (n=23) received MDI plus CGM. Participants in the experimental group received MDI plus CGM and the DSS (n=57) and were asked to use an “InControl Advice” app, which measured key values and made suggestions to users. Degludec basal insulin and Dexcom G5 CGM were used by all 80 participants. Researchers evaluated CGM-based and patient-reported outcomes.
Investigators also performed an ad hoc analysis in the DSS group to contrast active DSS users (n=18) vs nonactive DSS users (n=39), all of whom were classified based on a defined user score summarizing average daily number of interactions with key functionalities such as meal bolus calculator, bedtime advice, and exercise advise.
There were no significant differences between the experimental and control groups in terms of glycemic outcomes and patient reported outcomes at the end of the 14-week study.
In the control group, patients had reductions from baseline in glycated hemoglobin (HbA1c) (-0.4%; P =.009), coefficient of variation (-2.1%; P =.015), and mean average daily risk range (-3.5; P =.040). Patients in the experimental group had reductions in HbA1c (-0.3%; P =.001), higher time in range (+4.4%; P =.003), shorter time spent with CGM values of <60 (-0.7%; P =.049) and >250 mg/dL (-3.3%; P =.010), lower high blood glucose index (-1.3; P =.046), and lower average daily risk range (-2.4; P =.007).
Active DSS users had lower risk of and exposure to hypoglycemia with system use compared with nonactive DSS users. Hypoglycemia awareness was highest in active users vs nonactive users (P =.002).
Limitations of the study, according to the researchers, included issues with protocol adherence as well as the potential confounding effect of CGM on glycemic outcomes and patient-reported outcomes. Research coordinators said many participants who were using the InControl Advice app complained about “connectivity issues, alarm fatigue, and the need for high-quality data from the system to function properly.”
“People using MDI can seamlessly transition to smart insulin pens, which, in conjunction with CGM, make for an extraordinary depth of information that a well-designed DSS should leverage for improving quality of care,” the researchers concluded. “Further evaluation of factors important to individual with T1D users is needed to broaden interest among those with less optimal glycemic control in the use of these systems.”
Disclosure: Several study authors declared affiliations with pharmaceutical and device companies. Please see the original reference for a full list of authors’’ disclosures.
Bisio A, Anderson S, Norlander L, et al. Impact of a novel diabetes support system on a cohort of individuals with type 1 diabetes treated with multiple daily injections: a multicenter randomized study. Diabetes Care. Published online November 18, 2021. doi:10.2337/dc21-0838