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Completed

NCT Number: NCT01297946

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Conventional continuous subcutaneous insulin infusion therapy

Device

Dual-hormone closed-loop

Device

Primary outcomes

  1. 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.)

    Time frame: 4 p.m. - 7 a.m.

Secondary outcomes

  1. Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).

    Time frame: 4 p.m. - 7 a.m.

  2. 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.).

    Time frame: 4 p.m. - 7 a.m

  3. Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).

    Time frame: 11 p.m. - 7 a.m.

  4. Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).

    Time frame: 11 p.m. - 7 a.m.

  5. Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).

    Time frame: 11 p.m. - 7 a.m.

  6. Total insulin delivery.

    Time frame: 4 p.m. - 7 a.m.

  7. Total overnight insulin delivery (11 p.m. - 7 a.m.).

    Time frame: 11 p.m. - 7 a.m.

  8. Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.

    Time frame: 4 p.m. - 7 a.m.

  9. Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.

    Time frame: 4 p.m. - 7 a.m.

  10. Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.

    Time frame: 11 p.m. - 7 a.m

  11. Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.

    Time frame: 5:50 p.m. - 7:20 p.m

  12. Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.

    Time frame: 4 p.m. - 7 a.m.

  13. Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.

    Time frame: 11 p.m. - 7 a.m

  14. Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.

    Time frame: 5:50 p.m. - 7:20 p.m

  15. Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.

    Time frame: 4 p.m. - 7 a.m.

  16. Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.

    Time frame: 11 p.m. - 7 a.m

  17. Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.

    Time frame: 5:50 p.m. - 7:20 p.m

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Collaborators

  • Diabetes Québec
  • McGill University
  • Medtronic Minimed
  • Montreal Children's Hospital of the MUHC

Registry information

Official study 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

Acronym: CLASS-01

Important dates

First posted
Feb 17, 2011
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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