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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519102
First Posted: January 26, 2012
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
McGill University
Montreal Children's Hospital of the MUHC
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
  Purpose

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.


Condition Intervention Phase
Type-1 Diabetes Device: Dual Hormone closed-loop system Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHO-independent partial insulin bolus with closed-loop 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-dependent full insulin bolus combined with closed-loop 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.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519102


Locations
Canada, Quebec
Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
McGill University
Montreal Children's Hospital of the MUHC
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rémi Rabasa-Lhoret, Associate Professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT01519102     History of Changes
Other Study ID Numbers: CLASS-02
First Submitted: January 24, 2012
First Posted: January 26, 2012
Last Update Posted: December 10, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hormones
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists


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