Evaluation of a Diabetes Remote Monitoring Program Facilitated by Connected Glucose Meters for Patients With Poorly Controlled Type 2 Diabetes: Randomized Crossover Trial.

BACKGROUND: Patients with poorly controlled type 2 diabetes (T2D) experience increased morbidity, increased mortality, and higher cost of care. Self-monitoring of blood glucose (SMBG) is a critical component of diabetes self-management with established diabetes outcome benefits. Technological advancements in blood glucose meters, including cellular-connected devices that automatically upload SMBG data to secure cloud-based databases, allow for improved sharing and monitoring of SMBG data. Real-time monitoring of SMBG data presents opportunities to provide timely support to patients that is responsive to abnormal SMBG recordings. Such diabetes remote monitoring programs can provide patients with poorly controlled T2D additional support needed to improve critical outcomes.
OBJECTIVE: To evaluate 6 months of a diabetes remote monitoring program facilitated by cellular-connected glucose meter, access to a diabetes coach, and support responsive to abnormal blood glucose recordings greater than 400 mg/dL or below 50 mg/dL in adults with poorly controlled T2D.
METHODS: Patients (N=119) receiving care at a diabetes center of excellence participated in a two-arm, 12-month randomized crossover study. The intervention included a cellular-connected glucose meter and phone-based diabetes coaching provided by Livongo Health. The coach answered questions, assisted in goal setting, and provided support in response to abnormal glucose levels. One group received the intervention for 6 months before returning to usual care (IV/UC). The other group received usual care before enrolling in the intervention (UC/IV) for 6 months. Change in hemoglobin A1c (HbA1c) was the primary outcome, and change in treatment satisfaction was the secondary outcome.
RESULTS: Improvements in mean HbA1c were seen in both groups during the first 6 months (IV/UC -1.1%, SD 1.5 vs UC/IV -0.8%, SD 1.5; P<.001). After crossover, there was no significant change in HbA1c in IV/UC (mean HbA1c change +0.2, SD 1.7, P=.41); however, those in UC/IV showed further improvement (mean HbA1c change -0.4%, SD 1.0, P=.008). A mixed-effects model showed no significant treatment effect (IV vs UC) over 12 months (P=.06). However, participants with higher baseline HbA1c and those in the first time period experienced greater improvements in HbA1c. Both groups reported similar improvements in treatment satisfaction throughout the study.
CONCLUSIONS: Patients enrolled in the diabetes remote monitoring program intervention experienced improvements in HbA1c and treatment satisfaction similar to usual care at a specialty diabetes center. Future studies on diabetes remote monitoring programs should incorporate scheduled coaching components and involve family members and caregivers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03124043; https://clinicaltrials.gov/ct2/show/NCT03124043. ©Daniel J Amante, David M Harlan, Stephenie C Lemon, David D McManus, Oladapo O Olaitan, Sherry L Pagoto, Ben S Gerber, Michael J Thompson. Originally published in JMIR Diabetes (http://diabetes.jmir.org), 11.03.2021.

RCT Entities:   Population Interventions Outcomes