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
Condition: Diabete Mellitus; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Multiple Daily Injections: Slow acting insulin and Rapid acting insulin
Intervention type(s): Other
Intervention description(s): 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.
Intervention MeSH terms: Insulin; Insulin, Short-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
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:
MDI with Physician Adjusted Basal-Bolus Parameters
MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters (OA)
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple Daily Injections; type 1 diabetes; pediatrics; optimization algorithm