Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7, Canada
NCT Number: NCT05626725
Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Automated insulin delivery systems (AIDs) combine an insulin pump coupled via an algorithm with a continuous glucose monitor (CGM), allowing constant adjustment of insulin doses according to blood glucose levels. Despite the significant improvement in blood glucose parameters and quality of life with these systems, they are not available to everyone and more and more people with diabetes are resorting to home-made or do-it-yourself (DIY) systems to access this technology. DIY systems are not approved or regulated by Health Canada, despite the growing interest. There have been no studies looking at this type of system in active people living with DbT1, including the risk of exercise-induced hypoglycemia.
The primary objective of this study is to evaluate the safety and efficacy of IDA systems in physically active individuals living with type 1 diabetes.This is a real-life observational study in people with commercial IDA (control group) and IDA-DIY. This study includes only one inclusion visit (which may be virtual) and the observation period is 6 weeks.
Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They will be required to wear a watch to record physical activity (FitBit). We will ask them to complete information about their diet at least twice a week for a whole day (Keenoa application).
Finally, participants will be asked to complete a physical activity diary to complete data (carbohydrates in prevention of activity, insulin suspension, hypoglycemia during or after exercise, etc.).
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Montreal, Quebec, H2W 1R7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an outpatient prospective observational study to evaluate the effect of DIY-AID use on maintaining glucose levels in physically active adult people living with T1D.
Time frame: 6 weeks
nadir: the lowest point on a glucose curve
Time frame: 6 weeks
Number of hypoglycemic events
Time frame: 6 weeks
Number of hypoglycemic events
Time frame: 6 weeks
Time (min and percentage) with glucose levels a. between 3.9 and 10.0 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L
Time frame: 6 weeks
Time (min and percentage) with glucose levels a. between 3.9 and 10.0 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L
Time frame: 6 weeks
Carbohydrate intake (g), timing and purpose of CHO intake prior to, during and within 30-min following PA.mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L
Time frame: 6 weeks
Carbohydrate intake (g), timing and purpose of CHO intake prior to, during and within 30-min following PA.mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L
Time frame: 6 weeks
Glucose variability: Standard deviation (SD) and coefficient of variance (CV) of glucose levels
Time frame: 6 weeks
Glucose variability: Standard deviation (SD) and coefficient of variance (CV) of glucose levels
Time frame: 6 weeks
Insulin delivery
Time frame: 6 weeks
Insulin delivery
Institut de Recherches Cliniques de Montreal
Other
An Observational Study to Assess the Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes in Free-living Conditions (AIDE-1)
Acronym: AIDE-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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