A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users

August 29, 2023 updated by: McGill University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • CIUSSS West-Central Montreal, Jewish General Hospital
        • Contact:
        • Principal Investigator:
          • Tricia Peters, MD
      • Montréal, Quebec, Canada
        • Recruiting
        • McGill University Health Centre
        • Principal Investigator:
          • Michael Tsoukas, MD
        • Sub-Investigator:
          • Ahmad Haidar, PhD
        • Sub-Investigator:
          • Natasha Garfield, MD
        • Sub-Investigator:
          • Jean-Francois Yale, MD
        • Sub-Investigator:
          • Laurent Legault, MD
        • Sub-Investigator:
          • Julia Von Oettingen, MD
        • Sub-Investigator:
          • Robert Kearney, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females ≥ 18 years of age
  2. 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.
  3. Undergoing multiple daily injection therapy.
  4. Baseline HbA1c value ≥ 7.5% (up to 7 days before or after screening).

Exclusion Criteria:

  1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  2. Failure to comply with the study protocol or with the team's recommendations.
  3. Injection of isophane insulin (NPH) or any intermediate-acting insulin
  4. More than 1 slow-acting injection and unwilling to switch to once a day for the study
  5. Current or ≤ 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).
  6. Pregnancy
  7. Severe hypoglycemic episode within one month of admission.
  8. Severe diabetic ketoacidosis episode within one month of admission
  9. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
  10. Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
  11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sensor-Augmented MDI + Mobile App (control)
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.
Device: Mobile App
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.
Experimental: Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm
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.
Device: Mobile App + Basal-Bolus Optimization Algorithm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c levels
Time Frame: Pre-intervention and post-intervention, approximately 12 weeks
Difference in HbA1c levels from the start to the end of the study
Pre-intervention and post-intervention, approximately 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients that achieve an HbA1c at the end-of-study visit of:
Time Frame: Post-intervention, approximately 12 weeks
a. less than or equal to 7.0%; b. less than or equal to 6.5%
Post-intervention, approximately 12 weeks
Percentage of time of sensor glucose levels spent:
Time Frame: 12 weeks
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.
12 weeks
Percentage of overnight time (23:00-7:00) of sensor glucose levels:
Time Frame: 12 weeks
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.
12 weeks
Percentage of daytime (7:00-23:00) of sensor glucose levels:
Time Frame: 12 weeks
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.
12 weeks
Standard deviation of glucose levels.
Time Frame: 12 weeks
Standard deviation of glucose levels as a measure of glucose variability.
12 weeks
Total insulin delivery.
Time Frame: 12 weeks
Total insulin delivery
12 weeks
Mean sensor glucose level during:
Time Frame: 12 weeks
a. the overall study period; b. the daytime period; c. overnight period.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire
Time Frame: Pre-intervention, then monthly, approximately 12 weeks
Scoring for treatment satisfaction ranges from 0-6; higher score = higher satisfaction (patient-reported outcomes)
Pre-intervention, then monthly, approximately 12 weeks
Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire
Time Frame: Post-intervention, approximately 12 weeks
Scoring for the usability of the app ranges from 1-7; higher score = higher usability (patient-reported outcomes)
Post-intervention, approximately 12 weeks
Recurrent themes from semi-structured interviews
Time Frame: Post-intervention, approximately 12 weeks
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.
Post-intervention, approximately 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Investigators

  • Principal Investigator: Michael Tsoukas, MD, RI-MUHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-5887

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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