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

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ClinicalTrials.gov Identifier: NCT05041621
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
McGill University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Sensor augmented MDI therapy plus mobile application Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official 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.
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sensor augmented MDI therapy plus mobile application with reinforcement learning algorithm
Participants with type 1 diabetes will undergo sensor-augmented MDI therapy for 4 months using a freestyle libre glucose sensor (Abbott Diabetes Care) and a mobile application integrated with the reinforcement learning algorithm.
Device: Sensor augmented MDI therapy plus mobile application

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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Females and males ≥ 18 years old
  3. Diagnosis of type 1 diabetes of ≥ 12 months based on the clinical investigator's judgement
  4. Undergoing MDI therapy
  5. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041621


Contacts
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Contact: Adnan Jafar, PhD Student +1 4383456595 adnan.jafar@mail.mcgill.ca
Contact: Alessandra Kobayati, PhD Student +1 5145010326 alessandra.kobayati@mail.mcgill.ca

Locations
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Canada, Quebec
Clinique Médicale Hygea Recruiting
Montreal, Quebec, Canada, H4A 3T2
Contact: Michael Tsoukas    (514) 967 9503    michael.tsoukas@mcgill.ca   
Principal Investigator: Michael Tsoukas, MD         
Sub-Investigator: Ahmad Haidar, PhD         
Sub-Investigator: Jean François YALE, MD         
Sub-Investigator: Julia Von Oettingen, MD         
Sub-Investigator: Laurent Legault, ND         
Sub-Investigator: Natasha Garfield, MD         
Sponsors and Collaborators
McGill University
Investigators
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Study Chair: Ahmad Haidar, PhD McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Michael Tsoukas, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT05041621    
Other Study ID Numbers: 2021-47375
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The raw data (insulin delivery, glucose levels, individual participant data) could be shared by the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes, subject to Material Transfer Agreement and approval of McGill University Health Center's Research Ethics Board. All data shared will be deidentified. Study protocol is available with publication.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Raw data and consent form: Anytime upon reasonable request. Protocol: After publication
Access Criteria: The requested data could be accessed from the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes. Protocol is available with publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases