- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Sainte-Agathe-des-Monts, Quebec, Canada, J8C 2Z7
- Camp Carowanis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females between 8 and 18 years old.
- 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.
- HbA1c ≤ 11%.
Exclusion Criteria:
- 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 team's recommendations.
- Injection of isophane insulin (NPH) or any intermediate-acting insulin
- More than one injection of slow-acting insulin per day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: MDI with Basal-Bolus Optimization Algorithm
Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care).
Once daily, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run.
Once daily, participants' parameters may be changed based on the algorithm's recommendations.
|
Multiple daily injections (MDI) therapy involves four or more daily insulin injections.
Once or twice daily, a long acting insulin is injected as a basal dose.
These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection.
This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day.
Furthermore, multiple insulin bolus doses are injected at every meal each day using rapid or short acting insulin.
These injections are administered before meals and are calculated using patients' ICRs and meal carbohydrate quantities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L).
Time Frame: the last 7 days of the study.
|
the last 7 days of the study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of time of sensor glucose levels spent:
Time Frame: last 7 days of the study
|
a. 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.
|
last 7 days of the study
|
Percentage of overnight time (23:00-7:00) of sensor glucose levels
Time Frame: last 7 days of the study
|
a. 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.
|
last 7 days of the study
|
Percentage of daytime (7:00-23:00) of sensor glucose levels
Time Frame: last 7 days of the study
|
a. 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.
|
last 7 days of the study
|
Standard deviation of glucose levels as a measure of glucose variability
Time Frame: last 7 days of the study
|
last 7 days of the study
|
|
Total insulin delivery.
Time Frame: last 7 days
|
last 7 days
|
|
Mean sensor glucose level during
Time Frame: last 7 days
|
a. the overall study period; b. the daytime period; c. overnight period.
|
last 7 days
|
Number of participants experiencing hypoglycemia requiring oral treatment during
Time Frame: last 7 days
|
a. the overall study period; b. the daytime period; c. overnight period.
|
last 7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDI Optimization Algorithm
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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