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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041621
• Other study ID #: 2021-47375
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: February 21, 2023

Study information

• Verified date: November 2023
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	Clinique Médicale Hygea	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		First and last month of intervention, approximately 4 months
Primary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last month of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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		First and last week of intervention, approximately 4 months
Secondary	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)		Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months
Secondary	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)		Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months
Secondary	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)		Post-intervention, approximately 4 months