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Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Single-hormone closed-loop strategy
Dual-hormone closed-loop strategy
Insulin pump therapy
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females between the 8 and 17 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.
  • HbA1c ≤ 11.0%.

Exclusion Criteria:

  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  • Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
  • Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
  • Known or suspected allergy to the trial products.
  • Other 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 team's recommendations (e.g. not willing to use trial pump, etc).

Sites / Locations

  • Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Insulin pump therapy

Single-hormone closed-loop strategy

Dual-hormone closed-loop strategy

Arm Description

Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..

Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.

Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

Outcomes

Primary Outcome Measures

Percentage of time of glucose levels spent below 4.0 mmol/L.

Secondary Outcome Measures

Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L
Percentage of time of glucose levels spent below 3.5 mmol/L
Percentage of time of glucose levels spent below 3.3 mmol/L
Percentage of time of glucose levels spent above 8 mmol/L
Percentage of time of glucose levels spent above 10 mmol/L.
Area under the curve of glucose levels below 4.0 mmol/L
Area under the curve of glucose levels below 3.5 mmol/L
Area under the curve of glucose levels below 3.3 mmol/L
Area under the curve of glucose levels above 8.0 mmol/L
Area under the curve of glucose levels above 10.0 mmol/L.
Mean glucose levels.
Standard deviation of glucose levels
Measure of glucose variability.
Total insulin delivery
Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L
Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L

Full Information

First Posted
July 3, 2014
Last Updated
September 1, 2014
Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Montreal Children's Hospital of the MUHC
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1. Study Identification

Unique Protocol Identification Number
NCT02189694
Brief Title
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp
Official Title
An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Overnight Glucose Levels in Children With Type 1 Diabetes in a Diabetes Camp
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Montreal Children's Hospital of the MUHC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia
Detailed Description
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin pump therapy
Arm Type
Active Comparator
Arm Description
Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..
Arm Title
Single-hormone closed-loop strategy
Arm Type
Active Comparator
Arm Description
Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.
Arm Title
Dual-hormone closed-loop strategy
Arm Type
Active Comparator
Arm Description
Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.
Intervention Type
Device
Intervention Name(s)
Single-hormone closed-loop strategy
Intervention Description
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Intervention Type
Device
Intervention Name(s)
Dual-hormone closed-loop strategy
Intervention Description
Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.
Intervention Type
Device
Intervention Name(s)
Insulin pump therapy
Intervention Description
Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Primary Outcome Measure Information:
Title
Percentage of time of glucose levels spent below 4.0 mmol/L.
Time Frame
Up to 8 hours
Secondary Outcome Measure Information:
Title
Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L
Time Frame
Up to 8 hours
Title
Percentage of time of glucose levels spent below 3.5 mmol/L
Time Frame
Up to 8 hours
Title
Percentage of time of glucose levels spent below 3.3 mmol/L
Time Frame
Up to 8 hours
Title
Percentage of time of glucose levels spent above 8 mmol/L
Time Frame
Up to 8 hours
Title
Percentage of time of glucose levels spent above 10 mmol/L.
Time Frame
Up to 8 hours
Title
Area under the curve of glucose levels below 4.0 mmol/L
Time Frame
Up to 8 hours
Title
Area under the curve of glucose levels below 3.5 mmol/L
Time Frame
Up to 8 hours
Title
Area under the curve of glucose levels below 3.3 mmol/L
Time Frame
Up to 8 hours
Title
Area under the curve of glucose levels above 8.0 mmol/L
Time Frame
Up to 8 hours
Title
Area under the curve of glucose levels above 10.0 mmol/L.
Time Frame
Up to 8 hours
Title
Mean glucose levels.
Time Frame
Up to 8 hours
Title
Standard deviation of glucose levels
Description
Measure of glucose variability.
Time Frame
Up to 8 hours
Title
Total insulin delivery
Time Frame
Up to 8 hours
Title
Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L
Time Frame
Up to 8 hours
Title
Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L
Time Frame
Up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females between the 8 and 17 years of old. Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months. HbA1c ≤ 11.0%. Exclusion Criteria: Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit. Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable. Known or suspected allergy to the trial products. Other 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 team's recommendations (e.g. not willing to use trial pump, etc).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret, MD, PhD
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26066705
Citation
Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, Rabasa-Lhoret R. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.
Results Reference
derived

Learn more about this trial

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

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