NCT03709108

Safety and Feasibility of an Insulin Sensitivity-Informed Bolus Calculator in Type 1 Diabetes

Completed NA Last updated 17 July 2024

What this trial tests

NA trial testing SI-Informed Bolus Calculator in Type 1 Diabetes Mellitus in 15 participants. Completed in 31 March 2019.

Timeline

19 November 2018

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	15
Start date	19 November 2018
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across United States

Drugs / interventions tested

• SI-Informed Bolus Calculator

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

University of Virginia

Who can join

Adults 18 to 65, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-center randomized crossover trial. The investigators will target completion of 15 adults (age 18-65 years) with Type 1 Diabetes who use an insulin pump. After completion of the Screening Visit, each subject will participate in a 28-day at home Data Collection Period while using their personal insulin pump, a personal glucometer, a study CGM, and a study activity tracker (i.e., Fitbit). This data collection period may be extended to obtain to gather more days of quality data, if needed per principal investigator judgement.

Once the data has been collected and processed, subjects will participate in two 24-hour admissions (Experimental and Control Admission) in a semi-controlled environment (i.e., hotel), performed in the assigned random order. During both admissions, subjects will use the personal insulin pump and glucometer, and a study CGM. The exercise session will consist of three 15-minute bouts of moderate-intensity exercise (i.e., stationary bicycle). Subjects will be provided a controlled dinner; the SI-informed bolus calculator will be used in the Experimental Admission while standard therapy will be used in the Control Admission. Subjects will then be observed overnight and discharged in the following morning.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Use of a Smart Bolus Calculator Informed by Real-time Insulin Sensitivity Assessments Reduces Postprandial Hypoglycemia Following an Aerobic Exercise Session in Individuals With Type 1 Diabetes.
   Fabris C, Nass RM, Pinnata J, Carr KA, et al · · 2020 · cited 17× · PMID 32144167 · DOI 10.2337/dc19-1675