- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041621
A Learning Algorithm for MDI Individuals With Type 1 Diabetes to Adjust Recommendations for High Fat Meals and Exercise Management
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adnan Jafar, PhD Student
- Phone Number: +1 4383456595
- Email: adnan.jafar@mail.mcgill.ca
Study Contact Backup
- Name: Alessandra Kobayati, PhD Student
- Phone Number: +1 5145010326
- Email: alessandra.kobayati@mail.mcgill.ca
Study Locations
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Quebec
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Montreal, Quebec, Canada, H4A 3T2
- Clinique Médicale Hygea
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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First and last month of intervention, approximately 4 months
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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
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First and last month of intervention, approximately 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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First and last month of intervention, approximately 4 months
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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
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First and last month of intervention, approximately 4 months
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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
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First and last month of intervention, approximately 4 months
|
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
|
First and last month of intervention, approximately 4 months
|
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
|
First and last month of intervention, approximately 4 months
|
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
|
First and last month of intervention, approximately 4 months
|
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
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First and last month of intervention, approximately 4 months
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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
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First and last month of intervention, approximately 4 months
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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
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First and last month of intervention, approximately 4 months
|
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
|
First and last month of intervention, approximately 4 months
|
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
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First and last month of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
|
First and last week of intervention, approximately 4 months
|
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
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Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months
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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
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Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months
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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
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Post-intervention, approximately 4 months
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-47375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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