Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes

Type 1 Diabetes Clinical Trial

— CLASS-01  

Official title:

An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Dual-hormone Closed-loop Strategy as Compared to Conventional CSII Therapy in Regulating Glucose Levels in Adults With Type-1 Diabetes in the Context of Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297946
• Other study ID #: CLASS-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 15, 2011
• Last updated: April 20, 2012

Study information

• Verified date: January 2012
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 1 diabetes for at least one year.

• On insulin pump therapy for at least 3 months.

• HbA1c = 10%.

Exclusion Criteria:

• Clinically significant nephropathy, neuropathy or retinopathy.

• Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

• A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.

• Pregnancy.

• Severe hypoglycemic episode within two weeks of screening.

• Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).

• 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.

• Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).

• Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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:
• Conventional continuous subcutaneous insulin infusion therapy

• Dual-hormone closed-loop

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)		4 p.m. - 7 a.m.	No
Secondary	Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).		4 p.m. - 7 a.m.	No
Secondary	Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).		4 p.m. - 7 a.m	No
Secondary	Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).		11 p.m. - 7 a.m.	No
Secondary	Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).		11 p.m. - 7 a.m.	No
Secondary	Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).		11 p.m. - 7 a.m.	No
Secondary	Total insulin delivery.		4 p.m. - 7 a.m.	No
Secondary	Total overnight insulin delivery (11 p.m. - 7 a.m.).		11 p.m. - 7 a.m.	No
Secondary	Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.		4 p.m. - 7 a.m.	No
Secondary	Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.		4 p.m. - 7 a.m.	No
Secondary	Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.		11 p.m. - 7 a.m	No
Secondary	Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.		5:50 p.m. - 7:20 p.m	No
Secondary	Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.		4 p.m. - 7 a.m.	No
Secondary	Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.		11 p.m. - 7 a.m	No
Secondary	Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.		5:50 p.m. - 7:20 p.m	No
Secondary	Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.		4 p.m. - 7 a.m.	Yes
Secondary	Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.		11 p.m. - 7 a.m	Yes
Secondary	Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.		5:50 p.m. - 7:20 p.m	Yes