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

McGill University

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Treatments: Device: Mobile App + Basal-Bolus Optimization Algorithm; Device: Mobile App

Study type: Interventional

Funder types: Other

Identifiers

NCT04123054

2020-5887

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Sensor-Augmented MDI + Mobile App (control)

Active Comparator group

Description:

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.

Treatment:

Device: Mobile App

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

Experimental group

Description:

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.

Treatment:

Device: Mobile App + Basal-Bolus Optimization Algorithm