Clinical trial NCT04123054: A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Keywords: Multiple Daily Injections,
Type 1 diabetes
Optimization algorithm
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c levels
timeFrame: Pre-intervention and post-intervention, approximately 12 weeks
Secondary outcomes:
measure: The number of patients that achieve an HbA1c at the end-of-study visit of:
timeFrame: Post-intervention, approximately 12 weeks
measure: Percentage of time of sensor glucose levels spent:
timeFrame: 12 weeks
measure: Percentage of overnight time (23:00-7:00) of sensor glucose levels:
timeFrame: 12 weeks
measure: Percentage of daytime (7:00-23:00) of sensor glucose levels:
timeFrame: 12 weeks
measure: Standard deviation of glucose levels.
timeFrame: 12 weeks
measure: Total insulin delivery.
timeFrame: 12 weeks
measure: Mean sensor glucose level during:
timeFrame: 12 weeks
Other outcomes:
measure: Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire
timeFrame: Pre-intervention, then monthly, approximately 12 weeks
measure: Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire
timeFrame: Post-intervention, approximately 12 weeks
measure: Recurrent themes from semi-structured interviews
timeFrame: Post-intervention, approximately 12 weeks
Locations:
city: Montreal
country: Canada
facility: CIUSSS West-Central Montreal, Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: RI-MUHC
name: Michael Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
References: