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

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ClinicalTrials.gov Identifier: NCT01297946
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : April 23, 2012
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Diabetes Québec
Medtronic Minimed
Investigators
Principal Investigator: Rémi Rabasa-Lhoret, M.D., Ph.D. Institut de Recherches Cliniques de Montréal (IRCM)
More Information

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
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: January 2012

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