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Trial record 65 of 780 for:    Area Under Curve AND meal

Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting (CLASS02)

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ClinicalTrials.gov Identifier: NCT01519102
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : December 10, 2012
Sponsor:
Collaborators:
McGill University
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 January 24, 2012
First Posted Date  ICMJE January 26, 2012
Last Update Posted Date December 10, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions [ Time Frame: 0-300min ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l). [ Time Frame: 0-300 min ]
  • Mean plasma glucose concentration.
  • Total insulin delivery
  • Total glucagon delivery
  • Plasma glucose concentration and incremental plasma glucose concentration at 2 hours postmeal
  • Postprandial peak and incremental postprandial peak of plasma glucose concentration
  • Percentage of time of plasma glucose concentrations spent in target range. Target range is defined to be between 4.0 and 10.0 mmol/l for 150 minutes postmeal and between 4.0 and 8.0 mmol/l afterwards
  • Percentage of postprandial time of plasma glucose concentrations spent in the low range (below 4.0mmol/l) [ Time Frame: 0-300min ]
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 Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
Official Title  ICMJE An Open-label, Randomized Two-way, Cross-over Study to Compare Meal-and-carbohydrate-announcement Strategy Versus Meal-announcement Strategy During Closed-loop Regulation of Glucose Levels in a Morning Meal in Adults With Type-1 Diabetes.
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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.

Each patient will be admitted twice to a clinical research facility. In one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. If post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study.

Detailed Description Not Provided
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: Dual Hormone closed-loop system
The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.
Study Arms  ICMJE
  • Active Comparator: CHO-independent partial insulin bolus with closed-loop
    Intervention: Device: Dual Hormone closed-loop system
  • Active Comparator: CHO-dependent full insulin bolus combined with closed-loop
    Intervention: Device: Dual Hormone closed-loop system
Publications * Haidar A, Farid D, St-Yves A, Messier V, Chen V, Xing D, Brazeau AS, Duval C, Boulet B, Legault L, Rabasa-Lhoret R. Post-breakfast closed-loop glucose control is improved when accompanied with carbohydrate-matching bolus compared to weight-dependent bolus. Diabetes Metab. 2014 Jun;40(3):211-4. doi: 10.1016/j.diabet.2013.12.001. Epub 2014 Mar 19.

*   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
Enrollment  ICMJE
 (submitted: January 25, 2012)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females ≥ 18 and ≤ 65 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 3 months) HbA1c ≤ 12%.

Exclusion Criteria:

  • Clinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.

    • Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin

  • Known or suspected allergy to the trial products or meal contents.
  • 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 eat snack, not willing to change pump parameters, etc).
  • Unreliable carbohydrate counting
  • Problems with venous access
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
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 NCT01519102
Other Study ID Numbers  ICMJE CLASS-02
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
  • McGill University
  • Montreal Children's Hospital of the MUHC
Investigators  ICMJE Not Provided
PRS Account Institut de Recherches Cliniques de Montreal
Verification Date December 2012

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