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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDI with Physician Adjusted Basal-Bolus Parameters | No Intervention | Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy. | |
| MDI with Basal-Bolus Optimization Algorithm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Daily Injections: Slow acting insulin and Rapid acting insulin | Other | 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. |
| Measure | Description | 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). | the last 7 days of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of sensor glucose levels spent: | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camp Carowanis | Sainte-Agathe-des-Monts | Quebec | J8C 2Z7 | Canada |
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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:
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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 | 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 | last 7 days of the study |
| Total insulin delivery. | last 7 days |
| Mean sensor glucose level during | a. the overall study period; b. the daytime period; c. overnight period. | last 7 days |
| Number of participants experiencing hypoglycemia requiring oral treatment during | a. the overall study period; b. the daytime period; c. overnight period. | last 7 days |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| ID | Term |
|---|---|
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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