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

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ClinicalTrials.gov Identifier: NCT02189694
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
Montreal Children's Hospital of the MUHC
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Percentage of time of glucose levels spent below 4.0 mmol/L. [ Time Frame: Up to 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L [ Time Frame: Up to 8 hours ]
  • Percentage of time of glucose levels spent below 3.5 mmol/L [ Time Frame: Up to 8 hours ]
  • Percentage of time of glucose levels spent below 3.3 mmol/L [ Time Frame: Up to 8 hours ]
  • Percentage of time of glucose levels spent above 8 mmol/L [ Time Frame: Up to 8 hours ]
  • Percentage of time of glucose levels spent above 10 mmol/L. [ Time Frame: Up to 8 hours ]
  • Area under the curve of glucose levels below 4.0 mmol/L [ Time Frame: Up to 8 hours ]
  • Area under the curve of glucose levels below 3.5 mmol/L [ Time Frame: Up to 8 hours ]
  • Area under the curve of glucose levels below 3.3 mmol/L [ Time Frame: Up to 8 hours ]
  • Area under the curve of glucose levels above 8.0 mmol/L [ Time Frame: Up to 8 hours ]
  • Area under the curve of glucose levels above 10.0 mmol/L. [ Time Frame: Up to 8 hours ]
  • Mean glucose levels. [ Time Frame: Up to 8 hours ]
  • Standard deviation of glucose levels [ Time Frame: Up to 8 hours ]
    Measure of glucose variability.
  • Total insulin delivery [ Time Frame: Up to 8 hours ]
  • Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L [ Time Frame: Up to 8 hours ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Device: Single-hormone closed-loop strategy
    Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
  • Device: Dual-hormone closed-loop strategy
    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.
  • Device: Insulin pump therapy
    Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Study Arms  ICMJE
  • Active Comparator: Insulin pump therapy
    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..
    Intervention: Device: Insulin pump therapy
  • Active Comparator: Single-hormone closed-loop strategy
    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.
    Intervention: Device: Single-hormone closed-loop strategy
  • Active Comparator: Dual-hormone closed-loop strategy
    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: Device: Dual-hormone closed-loop strategy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
22
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189694
Other Study ID Numbers  ICMJE CLASS-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Study Sponsor  ICMJE Institut de Recherches Cliniques de Montreal
Collaborators  ICMJE Montreal Children's Hospital of the MUHC
Investigators  ICMJE
Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD Institut de recherches cliniques de Montréal
PRS Account Institut de Recherches Cliniques de Montreal
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP