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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 10, 2020

Primary Completion Date

November 27, 2021

Study Completion Date

December 14, 2021

Conditions
Type 1 Diabetes
Interventions
DEVICE

Single-hormone closed-loop system

Every 10 minutes, the glucose levels as measured by the sensor will be transferred automatically to a LG Google Nexus Smartphone that the algorithm is running on, which will calculate the recommended doses and will send them wirelessly to the infusion pump.

DEVICE

Insulin pump

Tandem Diabetes Care

DEVICE

Continuous glucose monitoring system

Dexcom G6

DRUG

Aspart or Lispro

Aspart or lispro will be infused with the infusion pump

OTHER

Carbohydrate counting

Participants will be required to enter an estimate of the carbohydrate content of their meal into the phone. Insulin boluses will be calculated based on grams of carbohydrates and participant's insulin-to-carbohydrate ratio. Carbohydrate-matching full prandial bolus will be given 5 to 10 minutes before the meal.

OTHER

Simplified qualitative meal-size estimation strategy

A pre-meal partial prandial bolus will be given 5-10 minutes before the meal. The partial bolus will be based on the estimated meal size (small, regular, large and extra-large). The closed-loop system will give the remaining insulin needed based on the sensor readings. For this strategy, meal size will be defined as: small as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, extra-large meal for anything above 90g CHO.

OTHER

3-week intervention

Glucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks.

OTHER

1-hour postprandial exercise (sub-study)

60 minute exercise will be started one hour after the meal time.

OTHER

2-hour postprandial exercise (sub-study)

60 minute exercise will be started two hours after meal time

OTHER

Exercise announcement and meal bolus reduction (sub-study)

Meal bolus reduction of 33% at meal time and exercise announcement (increased target glucose from 6 to 9mmolL) to the CLS algorithm

Trial Locations (2)

H2W 1R7

Montreal Clinical Research Institute, Montreal

H4A 3J1

McGill University Health Center, Montreal

All Listed Sponsors
lead

Institut de Recherches Cliniques de Montreal

OTHER

NCT04031599 - Assessment of the Efficacy of the Artificial Pancreas Combined With a Qualitative Meal Size Estimation to Control Postprandial Glucose Levels | Biotech Hunter | Biotech Hunter