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Completed

NCT Number: NCT05041621

A Learning Algorithm for MDI Individuals With Type 1 Diabetes to Adjust Recommendations for High Fat Meals and Exercise Management

McGill artificial pancreas lab has developed a learning algorithm using a reinforcement learning approach to adjust basal and bolus recommendations for high-fat meals and exercise management for individuals with type 1 diabetes on multiple daily injections (MDI) therapy. The reinforcement learning algorithm is integrated with a mobile application that gathers insulin, meal information (carbs (if applicable) and high-fat content), mealtime glucose value, glucose trend at mealtime, and type and timing of postprandial exercise.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Médicale Hygea

Montreal, Quebec, H4A 3T2, Canada

About this study

The objective of this study is to assess the feasibility of a reinforcement learning algorithm to adjust basal and bolus recommendations for high-fat meals and postprandial exercise management. The investigators hypothesize that the reinforcement learning algorithm will be safe, and participants will get the benefit of improved glucose outcomes and improved patient satisfaction from the start to the end of study.

Participants (aged ≥18) will undergo multiple daily injections (MDI) therapy for 4 months using a freestyle Libre glucose sensor (Abbott Diabetes Care) and a mobile data collection application integrated with the reinforcement learning algorithm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated informed consent form
  • Females and males ≥ 18 years old
  • Diagnosis of type 1 diabetes of ≥ 12 months based on the clinical investigator's judgement
  • Undergoing MDI therapy
  • A self-reported diet that consists of at least 3 high-fat meals per week or participation in exercise for at least 30 minutes, two times per week

Exclusion criteria

  • Current use of any non-insulin antihyperglycemic medication (SGLT2 inhibitors, GLP 1 receptor agonists, metformin…)
  • Current use of glucocorticoid medication, except inhaled and/or at low stable doses
  • Pregnancy
  • Use of isophane insulin (NPH) or intermediate-acting insulin
  • Significant clinical nephropathy, neuropathy, retinopathy as per the clinical investigator's judgement
  • Acute macrovascular event (ex: acute coronary syndrome or cardiac surgery) within 6 months of admission
  • Severe diabetes ketoacidosis and/or hypoglycemia within one month of admission
  • Other severe medical illness that the clinical investigator considers may interfere with participation in or completion of the study
  • An inability or unwillingness to comply with study procedures as per the clinical investigator's judgement

Treatment and study plan

Sensor augmented MDI therapy plus mobile application

Device

Participants will use the mobile application to calculate their basal dose and to calculate their meal bolus dose by entering their glucose value, carbs (if applicable), fat composition (high fat or not), and type and timing of postprandial exercises. Participants will receive their dosing parameters weekly upon adjustments made by the reinforcement learning algorithm. Participants will be contacted by telephone on Weeks 1, 3, 5, and 7 in case of any technical difficulties or questions.

All participants will be asked to complete the:

(i) Diabetes treatment satisfaction questionnaire (DTSQ) and hypoglycemia fear survey-II (HFS-II) at baseline, halfway through the intervention, and post-intervention.

(ii) mHealth usability questionnaire (MAUQ) at post-intervention.

Primary outcomes

  1. Comparison of 5 hours postprandial incremental area under the curve of glucose (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  2. Comparison of 5 hours postprandial percentage of time below 3.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

Secondary outcomes

  1. Comparison of 5 hours postprandial percentage of time between 3.9 and 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  2. Comparison of 5 hours postprandial percentage of time between 3.9 and 7.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  3. Comparison of 5 hours postprandial percentage of time below 3.3 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  4. Comparison of 5 hours postprandial percentage of time below 2.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  5. Comparison of 5 hours postprandial percentage of time above 7.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  6. Comparison of 5 hours postprandial percentage of time above 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  7. Comparison of 5 hours postprandial percentage of time above 13.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  8. Comparison of 5 hours postprandial percentage of time above 16.7 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  9. Comparison of 5 hours postprandial mean glucose level (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  10. Comparison of 5 hours postprandial standard deviation of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  11. Comparison of 5 hours postprandial coefficient of variance of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last month of intervention, approximately 4 months

  12. Comparison of 24 hours incremental area under the curve of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  13. Comparison of 24 hours percentage of time below 3.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  14. Comparison of 24 hours percentage between 3.9 and 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  15. Comparison of 24 hours percentage between 3.9 and 7.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  16. Comparison of 24 hours percentage of time below 3.3 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  17. Comparison of 24 hours percentage of time below 2.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  18. Comparison of 24 hours percentage of time above 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  19. Comparison of 24 hours percentage of time above 13.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  20. Comparison of 24 hours percentage of time above 16.7 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  21. Comparison of 24 hours mean glucose level (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  22. Comparison of 24 hours standard deviation of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  23. Comparison of 24 hours coefficient of variance of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations

    Time frame: First and last week of intervention, approximately 4 months

  24. Quality of life measure by Hypoglycemic Fear Survey - II: score is the average of 18 items and each item scores ranges 1 to 5 to select (average of higher scores equates to more distress)

    Time frame: Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months

  25. Quality of life measure by Hypoglycemic Fear Survey - II: score is the average of 9 items and each item scores ranges 0 to 6 (average of higher scores equates to more satisfied with the treatment)

    Time frame: Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months

  26. Mobile app usability questionnaire: score is the average of 16 items and each item scores ranges 0-6 (average of higher scores means higher usability)

    Time frame: Post-intervention, approximately 4 months

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

A Single Arm Pilot Study to Assess the Feasibility of a Learning Algorithm to Automatically Adjust Basal and Bolus Recommendations for High Fat Meals and Exercise Management for Individuals With Type 1 Diabetes on MDI Therapy

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2021
Registry last updated
Nov 9, 2023

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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