Abstract
Telemedicine represents an important method of health care delivery for patients with complex chronic diseases, such as type 2 diabetes mellitus (T2D). Optimizing glycemic control often requires frequent outpatient clinic visits for medication adjustments. Indeed, most patients with T2D continue to be seen through traditional face-to-face visits. Given that 38 million Americans have diabetes mellitus 1 —and many face comorbidities that restrict mobility or live in remote areas—frequent in-person visits can be difficult to achieve. Moreover, many patients are treated with multiple daily insulin (MDI) regimens 2 and use point-of-care (POC) fingerstick testing for glucose monitoring.
Three emerging advancements in diabetes technology offer patients and health care providers (HCPs) reliable alternatives for obtaining glucose metrics and monitoring compliance. These include (1) continuous glucose monitoring (CGM) to provide sophisticated glucose tracking and gathering of high volumes of data continuously at frequent intervals; (2) smart insulin pens (SIPs) to record the timing and dosage of insulin 3 ; and (3) telemedicine to provide less time-consuming and accessible care, allowing for quicker optimization of medications and improving adherence to treatment. 4 Furthermore, physical activity (PA) improves glycemic control, decreases the risk of cardiovascular disease, and lowers mortality. 5 Despite the importance of this behavior, most patients with T2D remain physically inactive. 6
In this pilot randomized control trial (RCT), we examined the effectiveness and feasibility of a novel integrated telemedicine system to manage T2D, combining CGM, SIPs, formal consultation with an exercise physiologist (EP), and the use of telecommunication methods. The purpose was to examine whether our integrated telemedicine system could lead to improvement in hyperglycemia, defined by a decrease in HbA1c (primary outcome).
A total of 30 subjects were enrolled, 24 completed the study, 11 in the telemedicine group (73%), and 13 in the standard of care (SoC) group (86%). The telemedicine group had a mean baseline HbA1c of 9.4%, compared with 9.3% in SoC. Both groups exhibited a decrease in HbA1c from baseline at three months, a 2.2% reduction (95% confidence interval [CI] = −3.1, −1.3) in telemedicine and 1.0% (−1.9, −0.13) in SoC, with group difference of −1.2% (−2.5, 0.1) (P = .07) and a reduction of 2.2% (−3.2, −1.3) and 1.1% (−2.0, −0.2) for the telemedicine and SoC groups, respectively, with between-group difference of −1.1% at six months (−2.4, 0.2) (P = .09), favoring the telemedicine group. We also found a considerable reduction in TAR >250 mg/dL, but minor differences in time in range (TIR) 70 to 180 mg/dL, time above range (TAR) >180 mg/dL, TBR<70 mg/dL, and time below range (TBR) <54 mg/dL (Table 1). There were no differences between groups in the senior fitness test outcomes.
Glycemic Outcomes.
Data presented as mean ± SE or median (IQR).
Abbreviations: HbA1c, hemoglobin A1c; TIR, time in range; TAR, time above range; TBR, time below range; SD, standard deviation; CV, coefficient of variation.
Although no statistically significant differences were observed, overall trends favored the telemedicine group. Although previous studies have evaluated CGMs, SIPs, telecommunication systems, and PA individually, this study innovatively evaluates these components as an integrated telemedicine system. Larger RCTs are needed to evaluate whether our proposed telemedicine intervention can lead to better glycemic outcomes and serve as an alternative, improved method of providing care. Ultimately, this pilot study provides evidence supporting the necessity for further research to validate the advantages of telemedicine in T2D management.
Footnotes
Abbreviations
CGM, continuous glucose monitoring; EP, exercise physiologist; HbA1c, hemoglobin A1c; HCP, health care provider; MDI, multiple daily insulin; PA, physical activity; POC, point-of-care; RCT, randomized control trial; SIPs, smart insulin pens; SoC, standard of care; T2D, type 2 diabetes mellitus; TAR, time above range; TBR, time below range; TIR, time in range.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JDS was supported by the Baltimore VA Medical Center Geriatric Research, Education, and Clinical Center and by NIA P30AG028747. EKS has received research support from Dexcom and Tandem Diabetes for the conduct of clinical trials at the Baltimore VA and University of Maryland as well as research supplies from Insulclock for the conduct of the current study. FG-P has taken part in advisory panels for Insulcloud S.L., Sanofi, and Novo Nordisk; has received research support from Sanofi, Novo Nordisk, Boehringer Ingelheim Pharmaceuticals, and Lilly; and has acted as a speaker for Sanofi, Novo Nordisk, Boehringer Ingelheim Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co, and Lilly. FS, RH, LGS, MYC, CG, LP, WS, GIA, and MRB have nothing to disclose.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Dexcom and Insulclock provided devices only for the conduction of the clinical trial.
