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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabete Mellitus
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	Multiple Daily Injections: Slow acting insulin and Rapid acting insulin	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.

Timeline

• Start date: 2018-07-02
• Primary completion: 2018-08-10
• Completion: 2018-08-10
• First posted: 2018-12-05
• Last updated: 2019-08-15

Locations

1 site across 1 country: Canada