Accepted for/Published in: JMIR Diabetes
Date Submitted: Nov 6, 2020
Open Peer Review Period: Nov 6, 2020 - Nov 12, 2020
Date Accepted: Jan 9, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of a Diabetes Remote Monitoring Program Facilitated by Connected Glucose Meters for Patients with Poorly Controlled Type 2 Diabetes: A Randomized Crossover Trial.
ABSTRACT
Background:
Patients with poorly-controlled type 2 diabetes experience increased morbidity, 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 responsive to aberrant SMBG recordings. Such diabetes remote monitoring programs can provide patients with poorly-controlled T2D additional support needed to improve critical outcomes.
Objective:
To evaluate six 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 in adults with poorly controlled type 2 diabetes.
Methods:
Patients (n=120) participated in a two-arm, 12-month randomized crossover study. The intervention included a cellular-connected glucose meter and phone-based diabetes coaching. The coach answered questions, assisted in goal setting, and provided support in response to abnormal glucose levels. One group received the intervention for six months before returning to usual care (IV/UC). The other group received usual care before enrolling in the intervention (UC/IV) for six 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 six months (IV/UC -1.1% (SD 1.5) vs. UC/IV -0.8% (1.5), p < 0.001). After crossover, there was no significant change in HbA1c in IV/UC (mean HbA1c change +0.2 (1.7), p=0.41); however, those in UC/IV showed further improvement (mean (SD) HbA1c change -0.4% (1.0), p < 0.01). A mixed-effects model showed no significant treatment effect (IV vs. UC) over 12 months (p=0.06). However, participants with higher baseline HbA1c and those in 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 program should incorporate scheduled coaching components and involve family members and caregivers. Clinical Trial: Study details can be found at clinicaltrials.gov with the study identifier number: NCT03124043.
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Copyright
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