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

NCT03764280 | Completed

• 1 other identifier: MDI Optimization Algorithm
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Mellitus; Diabetes Mellitus, Type 1

Keywords

Multiple Daily Injections; type 1 diabetes; pediatrics; optimization algorithm

Outcome Measures

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).

  the last 7 days of the study.

Secondary Outcomes (7)

• Percentage of time of sensor glucose levels spent:

  last 7 days of the study

• Percentage of overnight time (23:00-7:00) of sensor glucose levels

  last 7 days of the study

• Percentage of daytime (7:00-23:00) of sensor glucose levels

  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

Study Arms (2)

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.

Other: Multiple Daily Injections: Slow acting insulin and Rapid acting insulin

Interventions

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.

MDI with Basal-Bolus Optimization Algorithm

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Camp Carowanis

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

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin, Short-Acting

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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: 1. MDI with Physician Adjusted Basal-Bolus Parameters 2. MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters (OA)

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: December 5, 2018
• Study Start: July 2, 2018
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

CA (1)