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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorMcGill University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Are pregnant or currently are breastfeeding

Don't speak French or English

Does not have a smart phone (to download applications)

Trial population

People living with type 1 diabetes

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Automated Insulin Delivery (AID) Systems

    Device

    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

    Behavioral

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Disordered Eating Behaviours

The primary outcome variable disordered eating behaviours will be measured through the Three Factor Eating Questionnaire-Revised 21 (TFEQ) in adults. The primary outcome for youth (12 to 17y) is the Child Three Factor Eating Questionnaire 17, which is an adapted questionnaire from the TFEQ. TFEQ refers to current dietary practice and measures 3 different aspects of eating behaviour: cognitive dietary restraint (conscious restriction of food intake) score ranges from 6 to 24, uncontrolled eating (tendency to eat more than usual due to loss of control over intake accompanied by subjective feelings of hunger) score ranges from 9 to 36, and emotional eating (inability to resist emotional cues) score ranges from 6 to 24. Higher scores in the respective scales indicate greater level of restrained, uncontrolled, or emotional eating.

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.
2

Diabetes Disordered Eating Behaviours

The Diabetes Eating Problem Survey (DEPS-R) is a 16-item questionnaire for youth and adults over the age of 12 years. It refers to disordered eating behaviours specific to people with type 1 diabetes. The score ranges from 0 to 80, with a higher score indicating higher risk of disordered eating.

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
3

Orthorexia Eating Behaviours

The Teruel Orthorexia Scale is a 17-item questionnaire, that is validated in both English and French. It measures 'healthy orthorexia' behaviours as well as behaviours related to 'orthorexia nervosa'. Healthy orthorexia describes individuals who have a high interest in healthy eating, but in a non-pathological dimension of orthorexia. This sub scales score ranges from 0 to 27. Orthorexia nervosa includes behaviours that are related to healthy eating that may cause malnutrition, emotional distress, and social impairment. This subscale ranges from 0 to 24. A higher score represents more orthorexia symptoms.

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

Secondary outcomes

1

Glucose Time In Range (TIR)

Time in Range (TIR) (%): glucose TIR is the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L. A higher TIR indicates improved glycemic levels. Guidelines recommend a TIR greater than 70% for most PwT1D.

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.
2

Coefficient of Variation (CV)

Coefficient of Variation (CV) is determined by dividing the standard deviation of blood glucose levels over a 14-day period, by the total mean glucose and multiplying by 100 to obtain a percentage. This value reflects the variability of glucose levels. A higher CV value indicates more glycemic variability.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McGill University

Lead sponsor

Laval University

Collaborator

Université de Montréal

Collaborator

University of Windsor

Collaborator