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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01297946
Other study ID # CLASS-01
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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