Clinical trial NCT05041621: A Learning Algorithm for MDI Individuals With Type 1 Diabetes to Adjust Recommendations for High Fat Meals and Exercise Management
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
Secondary outcomes:
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last month of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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
timeFrame: First and last week of intervention, approximately 4 months
measure: 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)
timeFrame: Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months
measure: 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)
timeFrame: Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months
measure: 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)
timeFrame: Post-intervention, approximately 4 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Médicale Hygea
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Ahmad Haidar, PhD
role: STUDY_CHAIR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Michael Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
References: