NCT03581968

Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp

Completed NA Last updated 29 November 2018

What this trial tests

NA trial testing Artificial Pancreas in Diabetes in 45 participants. Completed in 10 August 2018.

Timeline

2 July 2018

Primary endpoint
10 August 2018

10 August 2018

Quick facts

Lead sponsor	McGill University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	45
Start date	2 July 2018
Primary completion	10 August 2018
Estimated completion	10 August 2018
Sites	1 location across Canada

Drugs / interventions tested

• Artificial Pancreas

Conditions studied

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

Sponsor

McGill University

Who can join

Adults 8 to 21, any sex, with Diabetes or Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Our lab has developed an artificial pancreas system called the McGill Artificial Pancreas (MAP) for automating insulin delivery. Using patient's basal-bolus parameters (basal rates and ICRs), the artificial pancreas involves a control algorithm that modulates insulin infusion based on the sensor readings and meal information. However, because basal-bolus parameters are difficult to optimize, proper glycemic control is not always achieved. Therefore, we have developed a learning algorithm that estimates optimal basal-bolus parameters using data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal rates and ICRs.

The objective of this project is to test our artificial pancreas system with and without the learning algorithm using a randomized crossover design in between 31 and 67 children and adolescents at camp Carowanis. We hypothesize that adding a learning algorithm to the artificial pancreas will improve the performance of our artificial pancreas system by increasing the time spent in target glucose range (4mmol/L - 10mmol/L) compared with the artificial pancreas system alone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.