Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03764280
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2018-06-27
Brief Title:
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
Sponsor:
McGill University
Organization:
McGill University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 39 mmolL - 10mmolL
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 participants 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 patients 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 algorithms recommendations before they are entered into the patients camp file
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 participants 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 patients 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 algorithms recommendations before they are entered into the patients camp file
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None