Dataset Information

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

ABSTRACT:

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 A_1c (HbA_1c) was the primary outcome, and change in treatment satisfaction was the secondary outcome.

Results

Improvements in mean HbA_1c 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 HbA_1c in IV/UC (mean HbA_1c change +0.2, SD 1.7, P=.41); however, those in UC/IV showed further improvement (mean HbA_1c 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 HbA_1c and those in the first time period experienced greater improvements in HbA_1c. Both groups reported similar improvements in treatment satisfaction throughout the study.

Conclusions

Patients enrolled in the diabetes remote monitoring program intervention experienced improvements in HbA_1c 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.

SUBMITTER: Amante DJ

PROVIDER: S-EPMC7995078 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:DisclaimerIn an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.PurposeInpatient diabetes management involves frequent assessment of glucose levels for treatment decisions. Here we describe a program for inpatient real-time continuous glucose monitoring (rtCGM) at a community hospital and the accuracy of rtCGM-based glucose estimates.MethodsAdult inpatients with preexisting diabetes managed with intensive insulin therapy and a diagnosis of coronavirus disease 2019 (COVID-19) were monitored via rtCGM for safety. An rtCGM system transmitted glucose concentration and trending information at 5-minute intervals to nearby smartphones, which relayed the data to a centralized monitoring station. Hypoglycemia alerts were triggered by rtCGM values of ≤85 mg/dL, but rtCGM data were otherwise not used in management decisions; insulin dosing adjustments were based on blood glucose values measured via blood sampling. Accuracy was evaluated retrospectively by comparing rtCGM values to contemporaneous point-of-care (POC) blood glucose values.ResultsA total of 238 pairs of rtCGM and POC data points from 10 patients showed an overall mean absolute relative difference (MARD) of 10.3%. Clarke error grid analysis showed 99.2% of points in the clinically acceptable range, and surveillance error grid analysis showed 89.1% of points in the lowest risk category. It was determined that for 25% of the rtCGM values, discordances in rtCGM and POC values would likely have resulted in different insulin doses. Insulin dose recommendations based on rtCGM values differed by 1 to 3 units from POC-based recommendations.ConclusionrtCGM for inpatient diabetes monitoring is feasible. Evaluation of individual rtCGM-POC paired values suggested that using rtCGM data for management decisions poses minimal risks to patients. Further studies to establish the safety and cost implications of using rtCGM data for inpatient diabetes management decisions are warranted.

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