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

NCT04123054 | Completed

• 1 other identifier: 2020-5887
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Keywords

Multiple Daily Injections,; Type 1 diabetes; Optimization algorithm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The number of patients that achieve an HbA1c at the end-of-study visit of:

  Post-intervention, approximately 12 weeks

• Percentage of time of sensor glucose levels spent:

  12 weeks

• Percentage of overnight time (23:00-7:00) of sensor glucose levels:

  12 weeks

• Percentage of daytime (7:00-23:00) of sensor glucose levels:

  12 weeks

• Standard deviation of glucose levels.

  12 weeks

Other Outcomes (3)

• Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire

  Pre-intervention, then monthly, approximately 12 weeks

• Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire

  Post-intervention, approximately 12 weeks

• Recurrent themes from semi-structured interviews

  Post-intervention, approximately 12 weeks

Study Arms (2)

Sensor-Augmented MDI + Mobile App (control)

ACTIVE COMPARATOR

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

Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm

EXPERIMENTAL

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

Interventions

Mobile App DEVICE

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.

Sensor-Augmented MDI + Mobile App (control)

Mobile App + Basal-Bolus Optimization Algorithm DEVICE

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.

Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (2)

CIUSSS West-Central Montreal, Jewish General Hospital

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Related Publications (1)

• Kobayati A, El Fathi A, Garfield N, Legault L, Jafar A, Yale JF, Tsoukas MA, Haidar A. A Bayesian decision support system for automated insulin doses in adults with type 1 diabetes on multiple daily injections: a randomized controlled trial. Nat Commun. 2025 Sep 29;16(1):8593. doi: 10.1038/s41467-025-63671-0.

  PMID: 41022835 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michael Tsoukas, MD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: October 10, 2019
• Study Start: March 5, 2020
• Primary Completion: December 21, 2023
• Study Completion: January 12, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within one year of publication.
• Access Criteria: Access provided upon reasonable request.

Locations

CA (2)