NCT04123054Completed
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
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 15 Aug 2019
- Start date
- 5 Mar 2020
- Primary completion date
- 21 Dec 2023
- Lead sponsor
- McGill University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT04123054
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 5 Mar 2020 to the primary completion date, 21 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Lab values
- Current or ≤ 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).
Other
- 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
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CIUSSS West-Central Montreal, Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.