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Completed

NCT Number: NCT04123054

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

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.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIUSSS West-Central Montreal, Jewish General Hospital, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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%

  2. 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.

  3. 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.

  4. 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.

  5. Standard deviation of glucose levels.

    Time frame: 12 weeks

    Standard deviation of glucose levels as a measure of glucose variability.

  6. Total insulin delivery.

    Time frame: 12 weeks

    Total insulin delivery

  7. Mean sensor glucose level during:

    Time frame: 12 weeks

    a. the overall study period; b. the daytime period; c. overnight period.

Other outcomes

  1. 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)

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Oct 10, 2019
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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