Introduction & Objective: RCT aimed to assess if a Diabetes Advanced Telemedicine (DAT) clinic leads to improvement in glycemic control compared to standard of care (SoC).
Methods: Patients with type 2 diabetes (T2D) randomized to DAT or SoC. DAT used continuous glucose monitoring devices, smart insulin pens, telecommunication (i.e. video visits) with physical activity (PA) counseling by an exercise physiologist. SoC used glucometers, traditional insulin pens, in-person visits and PA counseling by providers. Primary outcome was change in HbA1c. Secondary outcomes were time in range (TIR) 70-180 mg/dl, time above range (TAR)>180 mg/dl, TAR>250 mg/dl and time below range (TBR)<70 mg/dl. ANCOVA was used, adjusted for baseline value to determine the relation between group and outcome, and report p-values of the interaction term, group*time. Exercise was evaluated by senior fitness test and assessed by Hedge’s g effect size.
Results: Twenty-four patients with T2D completed the trial. Non-statistically significant reductions in glucose metrics were seen. HbA1c decreased by 2.2% (DAT) vs 1.1% (SoC) (-1.1%, [-0.2, -1.8], p=0.076). TIR 70-180 mg/dL increased 17.3% vs 15.4% (+1.9%, [-16.1,15.5], p=0.984), TAR>180 mg/dL decreased 20.5% vs 17.9% (-2.6%, [-21.5,10.5], p=0.756), TAR>250 mg/dL decreased 17.1% vs 6.0% (-11.1%. [-20.3,2.7], p=0.375), TBR changed 0.41% vs -0.88% (+0.47, [-0.16,1.37], p=0.054), DAT vs. SoC, respectively. Fitness tests, completed by 60% of participants, showed improvements in medium strength (bicep curls g=0.90 /p=0.06, chair stands g=0.63/p=0.18), daily physical function (g=0.56/p=0.20), aerobic performance (6min walk test g=0.24/p=0.61), agility/flexibility (timed up and go g=-0.30/p=0.49, back stretch g=-0.51/p=0.26).
Conclusions: T2D patients managed by DAT had non-significant improvement in glucose control driven by decreased hyperglycemia > 250 mg/dl. Non-significant modest increase in PA observed.
F. Sotomayor: None. C. Gothong: None. R. Hernandez: None. M.Y. Choe: None. G.I. Ash: None. W.H. Scott: None. L. Pinault: None. F. Gomez-Peralta: Advisory Panel; Abbott. Speaker's Bureau; Abbott. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Advisory Panel; Insulcloud S.L. Speaker's Bureau; Medtronic. Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Advisory Panel; Sanofi. L.G. Singh: None. J.D. Sorkin: None. I. Spanakis: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc.
