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

This study has been completed.
Sponsor:
Collaborators:
McGill University
Montreal Children's Hospital
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier:
NCT01519102
First received: January 24, 2012
Last updated: December 7, 2012
Last verified: December 2012

January 24, 2012
December 7, 2012
January 2012
November 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01519102 on ClinicalTrials.gov Archive Site
  • Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l). [ Time Frame: 0-300 min ] [ Designated as safety issue: No ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type-1 Diabetes
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01519102
CLASS-02
No
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Institut de Recherches Cliniques de Montreal
  • McGill University
  • Montreal Children's Hospital
Not Provided
Institut de Recherches Cliniques de Montreal
December 2012

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