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

NCT01519102 | Completed Phase 2

• 1 other identifier: CLASS-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type-1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions

  0-300min

Secondary Outcomes (8)

• Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l).

  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

Study Arms (2)

CHO-independent partial insulin bolus with closed-loop

ACTIVE COMPARATOR

Device: Dual Hormone closed-loop system

CHO-dependent full insulin bolus combined with closed-loop

ACTIVE COMPARATOR

Device: Dual Hormone closed-loop system

Interventions

Dual Hormone closed-loop system DEVICE

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.

CHO-dependent full insulin bolus combined with closed-loop; CHO-independent partial insulin bolus with closed-loop

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• McGill University: collaborator
• Montreal Children's Hospital of the MUHC: collaborator

Study Sites (1)

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

• 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.

  PMID: 24656963 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

CA (1)