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

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: Completed
• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Mobile App; Device: Mobile App + Basal-Bolus Optimization Algorithm

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 (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • CIUSSS West-Central Montreal, Jewish General Hospital
    • Montréal, Quebec, Canada
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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:	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:	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:	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:	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.	Standard deviation of glucose levels as a measure of glucose variability.	12 weeks
Total insulin delivery.	Total insulin delivery	12 weeks
Mean sensor glucose level during:	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	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	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	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

• Sponsor: McGill University
• Investigators: Principal Investigator: Michael Tsoukas, MD, RI-MUHC

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): January 12, 2024

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): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Multiple Daily Injections,; Optimization algorithm
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2020-5887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data - after de-identification.
• IPD Sharing Time Frame: Within one year of publication.
• IPD Sharing Access Criteria: Access provided upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No