Recruiting

Automated Insulin Delivery

Sponsor:

McGill University

Code:

NCT07348432

Conditions

Insulin Dependent Diabetes Mellitus

Feeding and Eating Disorders

Eating Behavior

Type 1 Diabetes

Autoimmune Diseases

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Automated Insulin Delivery (AID) Systems

Carbohydrate Counting Inaccuracy Percentage

Study Details

Brief summary:

Type 1 diabetes is an autoimmune health condition that requires daily injections of insulin. Insulin allows the body to use energy from carbohydrates in food. Disordered eating behaviours, like restricting food intake to lose body weight, are more common in women and people with type 1 diabetes, compared to those without because they must practice carbohydrate counting. Carbohydrate counting means identifying, measuring, and planning carbohydrate intake to match insulin dosage. New technologies, such as automated insulin delivery (AID) systems adjust insulin delivery in a blood sugar responsive manner. AID is rapidly replacing conventional insulin delivery like injections or non-automated insulin pumps since it reduces management burden and improves blood sugar levels. It is not known if AID reduces food management and disordered eating behaviours. This study aims to: 1. investigate the relationship between AID and eating behaviours according to gender for youth (12 to 17 years), and adults (18 years and older). 2. Determine the limit of carbohydrate counting inaccuracy to maintain stable blood sugar levels according to insulin delivery method (AID, injections, or pumps). It is hypothesized that those who use AID will have lower disordered eating behaviours and will maintain stable blood sugar levels while allowing for higher carbohydrate counting inaccuracy. This will be a cross-sectional cohort study of people with type 1 diabetes who are 12 years of age or over. Participants will be recruited through the BETTER registry and social medias across Canada. This research is needed to improve nutrition guidelines for type 1 diabetes in the context of new technologies like AID. Evidence from this study may reduce food management burden, lower the risk of disordered eating behaviours, and prevent eating disorders and medical complications.

Conditions

Insulin Dependent Diabetes Mellitus

Feeding and Eating Disorders

Eating Behavior

Type 1 Diabetes

Autoimmune Diseases

Study ID

NCT07348432

Start date

Jul 29, 2024

Status verified date

Jan, 2026

Completion date

May 1, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 12 years of age or older
  • Living in Canada
  • Living with type 1 diabetes for more than 1 year
  • Using at least 2 insulin injections per day or using an insulin pump
  • Using current insulin delivery system for 3 months or more

Exclusion Criteria:

  • Are pregnant or currently are breastfeeding
  • Don't speak French or English
  • Does not have a smart phone (to download applications)

Study Design

Enrollment

106 participants

Anticipated

Interventions and Outcome Measures

Interventions

Automated Insulin Delivery (AID) Systems

AID automatically adjusts insulin delivery by using continuously measured blood glucose levels. AID use will be determined through the initial questionnaire through the following questions:

Do you currently use the pump as an automated insulin delivery system (connected to a CGM with automated insulin adjustments)? Yes, a commercial AID with control IQ (Tandem) or SmartGuard (Medtronic) Yes, a non-commercial open-source do-it yourself AID (e.g., Loop) No, they use it as a manual (non-automated) pump or with a suspend on low functionality (e.g., Basal IQ) I prefer not to answer I don't know

The type of AID system (hybrid, advanced hybrid, etc.) will also be confirmed.

The exposure variable will be coded as a binary-categorical variable of AID use (yes or no) with no representing all other non-AID insulin pumps or injections.

Carbohydrate Counting Inaccuracy Percentage

Carbohydrate counting inaccuracy: will be determined by subtracting the estimated carbohydrates (by participant) by the actual amount of carbohydrate (through diet analysis) divided by the actual amount of carbohydrate, multiplied by 100, to determined the percentage. Estimated carbohydrate counts will be entered at each meal and snack by the participant in a daily log provided to the participant. Carbohydrate amounts will be collected through a 4-day food diary through the phone application Keenoa (carb count from the app will be blinded to the participant), and reviewed by a research assistant with education in dietetics.

Primary outcome measure

  • Disordered Eating Behaviours [ Time Frame: Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026. ]
  • Diabetes Disordered Eating Behaviours [ Time Frame: Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026 ]
  • Orthorexia Eating Behaviours [ Time Frame: Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026 ]

Central Contacts and Locations

Central contacts

Locations

McGill University

Recruiting

Montreal, Quebec, Canada, H9X 3V9

More Information

Sponsor

McGill University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Automated Insulin Delivery
  • Disordered Eating Behaviours
  • Nutrition
  • Type 1 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by McGill University on 2026-01-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.