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

January 12, 2026 updated by: Anne-Sophie Brazeau, McGill University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: Type 1 diabetes occurs when the pancreas cannot produce insulin and a person must be given insulin exogenously. Managing this health condition involves strict diet planning including carbohydrate counting (i.e. identifying and counting carbohydrates to match insulin dose). In addition, to high food management burden, frequent bodyweight monitoring, and weight gain related to insulin usage, makes people living with type 1 diabetes more susceptible to disordered eating behaviours (like intentional food restriction), compared to those without. Automated insulin delivery systems (AID), which automatically adjusts insulin as a response to continuously measured blood glucose levels has shown to improve quality of life, and improve glycemic levels, however it's impact on eating behaviours and diet is unknown. There is also a need to determine the carbohydrate counting inaccuracy threshold to maintain glycemic stability depending on the type of delivery system used (AID vs. Not).

Objectives:

  1. Determine the relationship between AID and eating behaviours
  2. Determine the carbohydrate counting inaccuracy threshold to maintain glycemic stability and understand whether AID use modifies this relationship.

Methods: This is an observational cross-section analysis of people with type 1 diabetes.

Eligibility criteria included: those living with type 1 diabetes for more than 1 year, using at least 2 insulin injections per day or using an insulin pump, who were living in Canada, 12 years of age or older, and using their current insulin delivery system for 3 months or more.

Participants are excluded if they were pregnant/currently breastfeeding and did not speak English or French.

Demographic, and diabetes-related information (including AID use), are determined through an initial questionnaire, which takes about 15 minutes to complete. Disordered eating behaviours were determined through validated questionnaires. The Three Factor Eating Questionnaire (TFEQR-21) identified behaviours such as cognitive restraint (score ranged from 6 to 24), emotional eating (score ranged from 6 to 24), and uncontrolled eating (score ranged from 9 to 36). The Diabetes Eating Problem Survey Revised (DEPS-R) identified DEBs specific to diabetes (score ranged from 0 to 80 with > 20 representing those at risk of DEB). The Teruel Orthorexia Scale (TOS) identified orthorexia nervosa behaviours defined as an obsession with healthy eating which may lead to emotional impairments (score ranged from 0 to 24).

Dietary intake information will be collected through a 4 day picture food journal (3 weekdays and 1 weekend) application called Keenoa and analyzed by a Registered Dietitian.

Glycemic outcomes such as glucose time in range (TIR), which measures the amount of time glucose levels are between 3.9-10.0mmol/L, and Coefficient Variation, were reported through a 14 day CGM report (Clarity, Dexcom, Medtronic).

Physical activity will be measured through an Actigraph GT3X for 8 days.

Descriptive analysis will be completed at enrollment, to determine the mean (SD) socio-demographic information, eating behaviour scores and dietary intake (macro/micronutrient profile) by insulin delivery system (AID and injections/insulin pumps).

Multivariate linear regression will be used to determine the relationship between AID compared to injections/insulin pumps and disordered eating behaviour scores.

Secondly, carbohydrate counting inaccuracy will be determined by comparing participant reported carbohydrate counts measured in mean (SD) grams per meal to RD measured carbohydrate counts by analyzing 4-day dietary reports, as generated by Keenoa.

Carbohydrate counting inaccuracy threshold will be determined through multivariate linear regression by exploring the relationship between percent carbohydrate counting inaccuracy and % of glucose Time in Range and Coefficient Variation. Type of insulin delivery will be used as an effect modifier to determine how this relationship is modified by AID and injections/insulin pumps.

Study Type

Observational

Enrollment (Estimated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H9X 3V9
        • Recruiting
        • McGill University
        • Contact:
          • Anne-Sophie Brazeau, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

People living with type 1 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Time In Range (TIR)
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.
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.
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.
Coefficient of Variation (CV)
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

Laval University
Université de Montréal
University of Windsor

Investigators

  • Principal Investigator: Anne-Sophie Brazeau, PhD, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-07-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified data may be shared to other researchers upon request in order to ensure the study results are reproducible.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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