Telemonitoring vs. Standard Care in the Management of Diabetes

Self-management of diabetes can be more successful when telemonitoring is included. 

Patients on basal-bolus insulin therapy to manage their diabetes have often had difficulty understanding the ideal dose of bolus insulin needed to sufficiently contain their blood glucose levels. As a possible solution, physicians and patients in Europe use a medical device and software system known as DIABEO (DS) to overcome this challenge. The DS was previously used in a pilot study (TELEDIAB-1), which had patients with type 1 diabetes and resulted in a significant reduction in HbA1c levels.  

TELESAGE is a double-blind, randomized study conducted in 95 public and private sites. Participants were adult patients with type 1 and type 2 diabetes using DS over 12-months and randomized into three study arms: the standard care arm (arm1), DS arm (arm2), and DS with telemonitoring arm (arm3). The primary outcome being measured is the reduction rates of HbA1c levels from baseline. Secondary products are the app‘s usage to calculate insulin doses, the ability to predict glucose control, compliance to use the app, and the incidence of hypoglycemic events.  

For statistical testing, the ANCOVA covariance model, logistic regression models, and post hoc exploratory analyses were used to calculate all covariates. The study included 665 enrolled patients, and after randomization into the three study arms, all baselines were not statistically different from each other.  

The results from this study showed a significant reduction of HbA1c upon 12-month follow-up compared to arm1: arm2 vs arm1 = -0.41% [95% CI = -0.65 to -0.16], P = 0.001 and arm3 vs arm1 = -0.51% [95% CI = -0.73 to -0.30], (P ≤ 0.001). For the secondary outcomes, glycemic control significant decrease is only seen in baseline HbA1c ≤ 9.5% (arm2: P < 0.029; arm3: P = 0.005). Prediction of glucose control showed significant reduction in baseline of HbA1c > 9.5% (arm2: P = 0.036; arm3: P = 0.005) or <25 years of age (arm2: P = 0.002; arm3: P = 0.009). The utilization of the app was followed for one month and found that a large number has never used the app (arm2: 40% – 50% patients; arm3: 20% – 30% patients). When observing for hypoglycemic events, there were no significant differences between all study arms. 

The app’s proper monitoring has proven to reduce HbA1c, as seen in this study’s participants. Though the study had limited participation, it showed that patients only had to use the app at least once per day to reduce HbA1c and its clinical impact. This data provides lots of room for other apps established to help patients control their blood sugar levels by giving an insight into how to make the app more user-friendly and engaging. As seen from the study, patients in an urban area used the app less than those of rural areas, which can further be observed to help achieve better compliance.  

Practice Pearls: 

• DIABEO has shown a clinical and statistical reduction in HbA1c since it allowed patients more support and guidance on controlling their glucose levels. 
• HbA1c reduction was seen best when patients used DIABEO two or more times a day as it provides more data for the software to predict glucose control.  
• To optimize the app‘s effectiveness, patients will need more support from the nurses in telemonitoring. 

Franc S, Hanaire H, Benhamou P.DIABEO System Combining a Mobile App Software With and Without Telemonitoring Versus Standard Care: A Diabetes Technology & Therapeutics.Dec 2020.  

Eric Cheung, PharmD Candidate, USF Taneja College of Pharmacy