Clinical trial NCT03764280: The Efficacy of MDI Treatment With an Optimization Algorithm Adjusting Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
Official title: An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of MDI Treatment With Physician Adjusted and Optimization Algorithm Adjusted Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Mellitus
Diabetes Mellitus, Type 1
Keywords: Multiple Daily Injections
type 1 diabetes
pediatrics
optimization algorithm
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label, randomized, two-way, parallel study to compare the glucose control between physician adjusted basal-bolus parameters and our computer basal-bolus optimizing algorithm. Children and adolescent type 1 diabetes patients at Camp Carowanis, a camp for diabetes, will be enrolled in the study, where they will randomly undergo one of two interventions:

1. MDI with Physician Adjusted Basal-Bolus Parameters
2. MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters (OA)
Primary purpose: TREATMENT

Brief summary: Our lab at McGill University has developed an optimization algorithm for T1D MDI patients that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate ratios) using glucose sensor data and insulin dosing data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal injections and ICRs. The investigators hope that this algorithm will be able to optimize the patients' individual basal injections and ICRs in order to improve glycemic control.

Detailed description: The objective of this project is to compare our basal-bolus optimization algorithm with physician adjusted basal-bolus parameters using a randomized parallel clinical trial in children and adolescents at a Camp Carowanis. The investigators hypothesize that using this optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters regarding time spent in target glucose range (3.9 mmol/L - 10mmol/L).

Between 40 and 68 children and adolescent type 1 diabetes patients undergoing MDI treatment at Camp Carowanis will randomly undergo one of two interventions:

1. MDI with Physician Adjusted Basal-Bolus Parameters: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy. At breakfast, the research team will download the sensor data. Camp physicians will review each participant's sensor and insulin data and make changes to their parameters based on their clinical judgement, as they would for all campers, regardless of study participation. These new parameters will be entered into the patient's camp file.
2. MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). At breakfast, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Camp physicians will review the algorithm's recommendations before they are entered into the patient's camp file.

Eligibility criteria: Inclusion Criteria:

1. Males and females between 8 and 18 years old.
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. HbA1c ≤ 11%.

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 team's recommendations.
3. Injection of isophane insulin (NPH) or any intermediate-acting insulin
4. More than one injection of slow-acting insulin per day.

Primary outcomes:
measure: Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L).
timeFrame: the last 7 days of the study.
Secondary outcomes:
measure: Percentage of time of sensor glucose levels spent:
timeFrame: last 7 days of the study
measure: Percentage of overnight time (23:00-7:00) of sensor glucose levels
timeFrame: last 7 days of the study
measure: Percentage of daytime (7:00-23:00) of sensor glucose levels
timeFrame: last 7 days of the study
measure: Standard deviation of glucose levels as a measure of glucose variability
timeFrame: last 7 days of the study
measure: Total insulin delivery.
timeFrame: last 7 days
measure: Mean sensor glucose level during
timeFrame: last 7 days
measure: Number of participants experiencing hypoglycemia requiring oral treatment during
timeFrame: last 7 days
Other outcomes:
Locations:
city: Sainte-Agathe-des-Monts
country: Canada
facility: Camp Carowanis
state: Quebec
Study officials:
References: