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

Type-1 Diabetes Clinical Trial

— CLASS02  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519102
• Other study ID #: CLASS-02
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2012
• Last updated: December 7, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type-1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut de Recherches Cliniques de Montréal (IRCM)	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	McGill University, Montreal Children's Hospital of the MUHC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions		0-300min	No
Secondary	Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l).		0-300 min	No
Secondary	Mean plasma glucose concentration.
Secondary	Total insulin delivery
Secondary	Total glucagon delivery
Secondary	Plasma glucose concentration and incremental plasma glucose concentration at 2 hours postmeal
Secondary	Postprandial peak and incremental postprandial peak of plasma glucose concentration
Secondary	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
Secondary	Percentage of postprandial time of plasma glucose concentrations spent in the low range (below 4.0mmol/l)		0-300min

External Links

•   Institut de Recherche Clinique de Montreal