NCT04031599

Assessment of the Efficacy of the Artificial Pancreas Combined With a Qualitative Meal Size Estimation to Control Postprandial Glucose Levels

Completed NA Last updated 28 January 2022

What this trial tests

NA trial testing Single-hormone closed-loop system in Type 1 Diabetes in 30 participants. Completed in 14 December 2021.

Timeline

10 July 2020

Primary endpoint
27 November 2021

14 December 2021

Quick facts

Lead sponsor	Institut de Recherches Cliniques de Montreal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	10 July 2020
Primary completion	27 November 2021
Estimated completion	14 December 2021
Sites	2 locations across Canada

Drugs / interventions tested

• Single-hormone closed-loop system
• Insulin pump
• Continuous glucose monitoring system
• Aspart or Lispro — full drug profile →
• Carbohydrate counting
• Simplified qualitative meal-size estimation strategy
• 3-week intervention
• 1-hour postprandial exercise (sub-study)
• 2-hour postprandial exercise (sub-study)
• Exercise announcement and meal bolus reduction (sub-study)

Conditions studied

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

Sponsor

Institut de Recherches Cliniques de Montreal — full company profile →

Who can join

18 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Postprandial glycemic excursions are major determinants of overall glycemic control in type 1 diabetes. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels. accurate carbohydrate counting is considered by patients as a significant burden and frustrating task.

The closed-loop system (CLS) is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The objective of this study is to compare the efficacy of two strategies to regulate glucose levels in outpatient settings in adults with type 1 diabetes: 1) single-hormone CLS with rapid acting insulin analogue combined with carbohydrate counting; 2) single-hormone CLS with rapid acting insulin analogue combined with simplified qualitative meal-size estimation.

A sub-study will also be proposed to participants. Postprandial exercise combines two situations complicating CLS operation: a high plasma insulin due to insulin on-board related to meal boluses and rapid blood glucose changes (postprandial blood glucose excursion and then drop during exercise) making input from the glucose sensor less accurate. The objective of this sub-study will be to explore the safety and efficacy of the CLS using the combined strategy of pre-meal exercise announcement and meal bolus reduction of 33% when exercise is performed 1 hour compared to 2 hours post meal time.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized Crossover Trial to Compare Automated Insulin Delivery (the Artificial Pancreas) With Carbohydrate Counting or Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes.
   Haidar A, Legault L, Raffray M, Gouchie-Provencher N, et al · · 2023 · cited 22× · PMID 37134305 · DOI 10.2337/dc22-2297
2. A Randomized Crossover Pilot Study Evaluating Glucose Control During Exercise Initiated 1 or 2 h After a Meal in Adults with Type 1 Diabetes Treated with an Automated Insulin Delivery System.
   Myette-Côté É, Molveau J, Wu Z, Raffray M, et al · · 2023 · cited 16× · PMID 36399114 · DOI 10.1089/dia.2022.0338