The Diabetes teleMonitoring of patients in insulin Therapy (DiaMonT) trial: study protocol for a randomized controlled trial.

BACKGROUND: The effect of telemedicine solutions in diabetes remains inconclusive. However, telemedicine studies have shown a positive trend in regards to glycemic control. The telemedicine interventions that facilitate adjustment of medication seems to improve glycemic control more effectively. Hence, it is recommended that future telemedicine studies for patients with diabetes include patient-specific suggestions for changes in medicine. Hence, the aim of the trial is to explore the effect of telemonitoring in patients with type 2 diabetes (T2D) on insulin therapy. METHODS: The trial is an open-label randomized controlled trial with a trial period of 3 months conducted in two sites in Denmark. Patients with T2D on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). The telemonitoring group will use a continuous glucose monitor (CGM), an insulin pen, an activity tracker, and smartphone applications throughout the trial. Hospital staff will monitor the telemonitoring group and contact the subjects by telephone repeatedly throughout the trial period. The usual care group will use a blinded CGM the first and last 20 days of the trial and will use a blinded insulin pen for the entire period. The primary endpoint will be changed from baseline in CGM time in range (3.9-10.0 mmol/L) 3 months after randomization. Secondary endpoints include change from baseline in glycated hemoglobin (HbA1c), total daily dose, time above range, and time below range 3 months after randomization. Exploratory endpoints include health-related quality of life, diabetes-related quality of life, etc. DISCUSSION: The DiaMonT trial will test a telemonitoring setup including various devices. Such a setup may be criticized, because it is impossible to determine which element(s) add to the potential effect. However, it is not possible and counterproductive to test the elements individually, since it is the full telemedicine setup that is being evaluated. The DiaMonT trial is the first Danish trial to explore the effect of telemonitoring on patients on insulin therapy. Thus, the DiaMonT trial has the potential to form the basis for the implementation of telemedicine for patients with T2D in Denmark. TRIAL REGISTRATION: ClinicalTrials.gov NCT04981808. Registered on 8 June 2021.

Correlation in Dose-Response to Rapid- and Long-Acting Insulin for People with Type 1 Diabetes.

In diabetes, it can become necessary to switch between pump- and pen-based insulin treatment. This switch involves a translation between rapid- and long-acting insulin analogues. In standard-of-care translation algorithms, a unit-to-unit conversion is applied. However, this simplification may not fit all individuals. In this paper, we investigate the correlation between dose-response to rapid- and long-acting insulin in the same individual, and compare the correlation across individuals. As a measure of dose-response, we estimate the insulin sensitivity in clinical data from 25 subjects with type 1 diabetes. For parameter estimation, we use maximum likelihood with a continuous-discrete extended Kalman filter and Bergman's minimal model. The results show a weak correlation between insulin sensitivity to rapid- and long-acting insulin across individuals. On this sparse data set, the analysis suggests that the standardized unit-to-unit translation between insulin analogues may not benefit all subjects.

An Adaptive Nonlinear Basal-Bolus Calculator for Patients With Type 1 Diabetes.

BACKGROUND: Bolus calculators help patients with type 1 diabetes to mitigate the effect of meals on their blood glucose by administering a large amount of insulin at mealtime. Intraindividual changes in patients physiology and nonlinearity in insulin-glucose dynamics pose a challenge to the accuracy of such calculators. METHOD: We propose a method based on a continuous-discrete unscented Kalman filter to continuously track the postprandial glucose dynamics and the insulin sensitivity. We augment the Medtronic Virtual Patient (MVP) model to simulate noise-corrupted data from a continuous glucose monitor (CGM). The basal rate is determined by calculating the steady state of the model and is adjusted once a day before breakfast. The bolus size is determined by optimizing the postprandial glucose values based on an estimate of the insulin sensitivity and states, as well as the announced meal size. Following meal announcements, the meal compartment and the meal time constant are estimated, otherwise insulin sensitivity is estimated. RESULTS: We compare the performance of a conventional linear bolus calculator with the proposed bolus calculator. The proposed basal-bolus calculator significantly improves the time spent in glucose target ( P < .01) compared to the conventional bolus calculator. CONCLUSION: An adaptive nonlinear basal-bolus calculator can efficiently compensate for physiological changes. Further clinical studies will be needed to validate the results.