Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes (CLASS-01)

This study has been completed.
Sponsor:
Collaborators:
McGill University
Montreal Children's Hospital of the MUHC
Diabète Québec
Medtronic Minimed
Information provided by:
Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier:
NCT01297946
First received: February 15, 2011
Last updated: April 20, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Conventional continuous subcutaneous insulin infusion therapy
Device: Dual-hormone closed-loop
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institut de Recherches Cliniques de Montreal:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l). [ Time Frame: 4 p.m. - 7 a.m. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Total insulin delivery. [ Time Frame: 4 p.m. - 7 a.m. ] [ Designated as safety issue: No ]
  • Total overnight insulin delivery (11 p.m. - 7 a.m.). [ Time Frame: 11 p.m. - 7 a.m. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l. [ Time Frame: 4 p.m. - 7 a.m. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l. [ Time Frame: 4 p.m. - 7 a.m. ] [ Designated as safety issue: No ]
  • Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l. [ Time Frame: 11 p.m. - 7 a.m ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l. [ Time Frame: 4 p.m. - 7 a.m. ] [ Designated as safety issue: Yes ]
  • Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l. [ Time Frame: 11 p.m. - 7 a.m ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Arms Assigned Interventions
Placebo Comparator: Open-loop
Conventional continuous subcutaneous insulin infusion (CSII) therapy
Device: Conventional continuous subcutaneous insulin infusion therapy
Experimental: Dual-hormone closed-loop
Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. The infusion rates are based on continuous glucose sensor reading and a control algorithm.
Device: Dual-hormone closed-loop

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297946

Locations
Canada, Quebec
Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
McGill University
Montreal Children's Hospital of the MUHC
Diabète Québec
Medtronic Minimed
Investigators
Principal Investigator: Rémi Rabasa-Lhoret, M.D., Ph.D. Institut de Recherches Cliniques de Montréal (IRCM)
  More Information

No publications provided by Institut de Recherches Cliniques de Montreal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rémi Rabasa-Lhoret, M.D., Ph.D., Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT01297946     History of Changes
Other Study ID Numbers: CLASS-01
Study First Received: February 15, 2011
Last Updated: April 20, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hormones
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014