Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp

NCT03581968 | Completed

• 1 other identifier: 2018-4269
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Our lab has developed an artificial pancreas system called the McGill Artificial Pancreas (MAP) for automating insulin delivery. Using patient's basal-bolus parameters (basal rates and ICRs), the artificial pancreas involves a control algorithm that modulates insulin infusion based on the sensor readings and meal information. However, because basal-bolus parameters are difficult to optimize, proper glycemic control is not always achieved. Therefore, we have developed a learning algorithm that estimates optimal basal-bolus parameters using data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal rates and ICRs. The objective of this project is to test our artificial pancreas system with and without the learning algorithm using a randomized crossover design in between 31 and 67 children and adolescents at camp Carowanis. We hypothesize that adding a learning algorithm to the artificial pancreas will improve the performance of our artificial pancreas system by increasing the time spent in target glucose range (4mmol/L - 10mmol/L) compared with the artificial pancreas system alone.

Conditions

Diabetes; Type 1 Diabetes Mellitus

Keywords

diabetes; type 1 diabetes; diabetes mellitus; pediatrics; diabetes camp

Outcome Measures

Primary Outcomes (1)

• Percentage of time of sensor glucose levels spent in target range

  Target range defined to be between 3.9 mmol/L and 10.0 mmol/L

  10-24hour periods

Secondary Outcomes (7)

• Percentage of time of sensor glucose levels spent

  10-24hour periods

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

  10-24hour periods

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

  10-24hour periods

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

  10-24hour periods

• Total insulin delivery.

  10-24hour periods

Study Arms (2)

Closed-loop therapy

EXPERIMENTAL

Participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. The closed-loop therapy will last 2 days (48 hours).

Device: Artificial Pancreas

Closed-loop therapy with learning module

EXPERIMENTAL

participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each day, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. The closed-loop therapy with the learning module will last 8 days (192 hours).

Device: Artificial Pancreas

Interventions

Artificial Pancreas DEVICE

The system is composed of 3 main components: 1. Insulin infusion pump to infuse insulin. The pump model used in the study is t:slim, Tandem Diabetes Care. 2. Continuous glucose monitor (CGM) to continuously measure glucose levels in the interstitial fluid. Glucose levels will be measured by Dexcom G5® CGM. 3. MAP application (iMAP) that computes insulin infusion based on the glucose values. The application also alarms the user when glucose sensor values are approaching the hypoglycemic or hyperglycemic range. The iMAP runs on an android smartphone. Every 10 minutes, iMAP retrieves the glucose values from the Dexcom G5 CGM via Bluetooth. The application computes an optimal insulin infusion rate based on i) the current glucose reading, ii) the glucose trend (i.e. how quickly the glucose level is rising or falling) and iii) the open-loop basal rates (study parameters). The insulin recommendations are then sent wirelessly via Bluetooth to the insulin pump.

Closed-loop therapy; Closed-loop therapy with learning module

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 21 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.
• The participant will have been on insulin pump therapy for at least 3 months.
• HbA1c ≤ 11%.

You may not qualify if:

• Participants who cannot or are unwilling to use NovoRapid (Aspart) insulin or Humalog (Lispro) insulin for the duration of the study.
• 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 (e.g. not willing to use trial pump, etc.).

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Camp Carowanis

Sainte-Agathe-des-Monts, Quebec, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Design

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

Model Details: This is an open-label, randomized, two-way, cross-over study.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: July 2, 2018
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)