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Diabetes MellitusNCT04123054

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

A study testing Mobile App and Mobile App + Basal-Bolus Optimization Algorithm in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by McGill University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Diabetes Mellitus, Type 1
What is being tested?
Mobile App and Mobile App + Basal-Bolus Optimization Algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
2 sitesCanada
Study dates
5 Mar 2020to 12 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • CIUSSS West-Central Montreal, Jewish General Hospital

    Montreal, Quebec

  • McGill University Health Centre

    Montreal, Quebec

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Mobile App, Mobile App + Basal-Bolus Optimization Algorithm
Keywords
Multiple Daily Injections,, Type 1 diabetes, Optimization algorithm
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile AppDevice

    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 AlgorithmDevice

    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.

Study groups in NCT04123054
Study groupRoleWhat they receive
Sensor-Augmented MDI + Mobile App (control)Active comparatorParticipants 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.
Receives: Device: Mobile App
Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization AlgorithmExperimentalParticipants 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.
Receives: Device: Mobile App + Basal-Bolus Optimization Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c levels

    Difference in HbA1c levels from the start to the end of the study

    Measured: Pre-intervention and post-intervention, approximately 12 weeks

Secondary outcomes (7)

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

    1. less than or equal to 7.0%; b. less than or equal to 6.5%

    Measured: Post-intervention, approximately 12 weeks

  2. Percentage of time of sensor glucose levels spent:

    1. 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.

    Measured: 12 weeks

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

    1. 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.

    Measured: 12 weeks

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

    1. 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.

    Measured: 12 weeks

  5. Standard deviation of glucose levels.

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

    Measured: 12 weeks

  6. Total insulin delivery.

    Total insulin delivery

    Measured: 12 weeks

  7. Mean sensor glucose level during:

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start5 Mar 2020
  3. Primary completion21 Dec 2023
  4. Study completion12 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123054
Sponsor's protocol ID
2020-5887
Status last verified
May 2024
First submitted
15 Aug 2019
Last updated
16 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant data - after de-identification.

Publications

  • 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.

    PubMed 41022835

Questions about this trial

What is this clinical trial studying?

A study testing Mobile App and Mobile App + Basal-Bolus Optimization Algorithm in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by McGill University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c levels (time frame: Pre-intervention and post-intervention, approximately 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04123054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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Clinical Trial NCT04123054 | AzTrials