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Completed

NCT Number: 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

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.

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Key information

Conditions

Diabete Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Camp Carowanis

Sainte-Agathe-des-Monts, Quebec, J8C 2Z7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Standard deviation of glucose levels as a measure of glucose variability

    Time frame: last 7 days of the study

  5. Total insulin delivery.

    Time frame: last 7 days

  6. Mean sensor glucose level during

    Time frame: last 7 days

    a. the overall study period; b. the daytime period; c. overnight period.

  7. 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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2018
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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