RecruitingNCT07348432

The diabEAT Study: Insulin dElivery Technologies And eaTing Behaviours in People With Type 1 Diabetes


Sponsor

McGill University

Enrollment

106 participants

Start Date

Jul 29, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This is a survey and data collection study exploring how different insulin delivery systems (such as injections versus insulin pumps) relate to eating behaviors and food choices in people with type 1 diabetes. Researchers want to understand if the type of insulin delivery device influences how people eat. **You may be eligible if...** - You are 12 years or older - You live in Canada - You have had type 1 diabetes for more than 1 year - You use at least 2 insulin injections per day or use an insulin pump - You have been using your current insulin delivery method for at least 3 months - You have a smartphone to download the study app **You may NOT be eligible if...** - You are pregnant or breastfeeding - You do not speak French or English - You do not have a smartphone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAutomated 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.

BEHAVIORALCarbohydrate 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.


Locations(1)

McGill University

Montreal, Quebec, Canada

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NCT07348432


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