Back to resultsA Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus, Type 1
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobile App
Mobile App + Basal-Bolus Optimization Algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Multiple Daily Injections,, Type 1 diabetes, Optimization algorithm
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 18 years of age
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Undergoing multiple daily injection therapy.
- Baseline HbA1c value ≥ 7.5% (up to 7 days before or after screening).
Exclusion Criteria:
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with the team's recommendations.
- Injection of isophane insulin (NPH) or any intermediate-acting insulin
- More than 1 slow-acting injection and unwilling to switch to once a day for the study
- Current or ≤ 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).
- Pregnancy
- Severe hypoglycemic episode within one month of admission.
- Severe diabetic ketoacidosis episode within one month of admission
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Sites / Locations
- CIUSSS West-Central Montreal, Jewish General HospitalRecruiting
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sensor-Augmented MDI + Mobile App (control)
Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm
Arm Description
Participants will continue their usual multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data.
Participants will undergo multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data. Every week, participants' insulin doses will be updated by the optimization algorithm's recommendations.
Outcomes
Primary Outcome Measures
Change in HbA1c levels
Difference in HbA1c levels from the start to the end of the study
Secondary Outcome Measures
The number of patients that achieve an HbA1c at the end-of-study visit of:
a. less than or equal to 7.0%; b. less than or equal to 6.5%
Percentage of time of sensor glucose levels spent:
a. between 3.9 and 7.8 mmol/L; b.between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d.below 3.3 mmol/L; e.below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Percentage of overnight time (23:00-7:00) of sensor glucose levels:
a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c.below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Percentage of daytime (7:00-23:00) of sensor glucose levels:
a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Standard deviation of glucose levels.
Standard deviation of glucose levels as a measure of glucose variability.
Total insulin delivery.
Total insulin delivery
Mean sensor glucose level during:
a. the overall study period; b. the daytime period; c. overnight period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04123054
Brief Title
A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
Official Title
An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Effectiveness of Multiple Daily Injection Treatment With an Insulin Dose Optimization Algorithm in Free-Living Outpatient Conditions in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGill University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.
Detailed Description
The changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous PRS update made in November of 2020. Therefore, this note serves to clarify the order of updates.
Inclusion: HbA1c ≥ 7.5% in the last 2 months (modification)
Exclusion:
More than 1 slow-acting injection and unwilling to switch to once a day for the study (addition)
Severe hypoglycemic episode within one month of admission (addition)
In the subsequent amendment, we modified the timeframe for the HbA1c inclusion criterion to obtain a more accurate representation of their current glucose control at the time of enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 1
Keywords
Multiple Daily Injections,, Type 1 diabetes, Optimization algorithm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an open-label, randomized, controlled, two-way parallel study to compare glucose control between sensor-augmented MDI therapy and our basal-bolus optimizing algorithm over 3 months. Adults with type 1 diabetes who are enrolled in the study will randomly undergo one of the two interventions for the entire study duration.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensor-Augmented MDI + Mobile App (control)
Arm Type
Active Comparator
Arm Description
Participants will continue their usual multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data.
Arm Title
Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm
Arm Type
Experimental
Arm Description
Participants will undergo multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data. Every week, participants' insulin doses will be updated by the optimization algorithm's recommendations.
Intervention Type
Device
Intervention Name(s)
Mobile App
Intervention Description
Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator.
Intervention Type
Device
Intervention Name(s)
Mobile App + Basal-Bolus Optimization Algorithm
Intervention Description
Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator. In addition, participants will receive weekly app notifications with personalized recommendations for insulin parameter adjustments made by the optimization algorithm.
Primary Outcome Measure Information:
Title
Change in HbA1c levels
Description
Difference in HbA1c levels from the start to the end of the study
Time Frame
Pre-intervention and post-intervention, approximately 12 weeks
Secondary Outcome Measure Information:
Title
The number of patients that achieve an HbA1c at the end-of-study visit of:
Description
a. less than or equal to 7.0%; b. less than or equal to 6.5%
Time Frame
Post-intervention, approximately 12 weeks
Title
Percentage of time of sensor glucose levels spent:
Description
a. between 3.9 and 7.8 mmol/L; b.between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d.below 3.3 mmol/L; e.below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Time Frame
12 weeks
Title
Percentage of overnight time (23:00-7:00) of sensor glucose levels:
Description
a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c.below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Time Frame
12 weeks
Title
Percentage of daytime (7:00-23:00) of sensor glucose levels:
Description
a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Time Frame
12 weeks
Title
Standard deviation of glucose levels.
Description
Standard deviation of glucose levels as a measure of glucose variability.
Time Frame
12 weeks
Title
Total insulin delivery.
Description
Total insulin delivery
Time Frame
12 weeks
Title
Mean sensor glucose level during:
Description
a. the overall study period; b. the daytime period; c. overnight period.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire
Description
Scoring for treatment satisfaction ranges from 0-6; higher score = higher satisfaction (patient-reported outcomes)
Time Frame
Pre-intervention, then monthly, approximately 12 weeks
Title
Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire
Description
Scoring for the usability of the app ranges from 1-7; higher score = higher usability (patient-reported outcomes)
Time Frame
Post-intervention, approximately 12 weeks
Title
Recurrent themes from semi-structured interviews
Description
Qualitative interview data to obtain an understanding of relationships by connecting lived experiences with a) mean survey scores and b) primary and secondary outcomes regarding the use of the study software on quality of life.
Time Frame
Post-intervention, approximately 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 18 years of age
Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
Undergoing multiple daily injection therapy.
Baseline HbA1c value ≥ 7.5% (up to 7 days before or after screening).
Exclusion Criteria:
Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Failure to comply with the study protocol or with the team's recommendations.
Injection of isophane insulin (NPH) or any intermediate-acting insulin
More than 1 slow-acting injection and unwilling to switch to once a day for the study
Current or ≤ 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).
Pregnancy
Severe hypoglycemic episode within one month of admission.
Severe diabetic ketoacidosis episode within one month of admission
Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Kobayati, BSc
Phone
514-501-0326
Email
alessandra.kobayati@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Anas El Fathi, PhD
Phone
1-434-956-0902
Email
anas.elfathi@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Tsoukas, MD
Organizational Affiliation
RI-MUHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS West-Central Montreal, Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Kobayati, BSc
Phone
514-501-0326
Email
alessandra.kobayati@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Tricia Peters, MD
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Kobayati, BSc
Email
alessandra.kobayati@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Ahmad Haidar, PhD
Email
ahmad.haidar@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Michael Tsoukas, MD
First Name & Middle Initial & Last Name & Degree
Ahmad Haidar, PhD
First Name & Middle Initial & Last Name & Degree
Natasha Garfield, MD
First Name & Middle Initial & Last Name & Degree
Jean-Francois Yale, MD
First Name & Middle Initial & Last Name & Degree
Laurent Legault, MD
First Name & Middle Initial & Last Name & Degree
Julia Von Oettingen, MD
First Name & Middle Initial & Last Name & Degree
Robert Kearney, PhD
12. IPD Sharing Statement
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A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
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