Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Institut de Recherches Cliniques de Montreal
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier:
NCT01966393
First received: October 17, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.

The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.


Condition Intervention Phase
Type 1 Diabetes
Other: 60-hours intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Glucose Levels During 60 Hours in Free-living Conditions in Patients With Type 1 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range. [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
    Hypoglycemic range is defined to be between below 4 mmol/L


Secondary Outcome Measures:
  • Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range. [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
    Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 8 mmol/L from 22:00 to 7:00.

  • Percentage of time of glucose levels spent below 3.5 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Percentage of time of glucose levels spent below 3.3 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Area under the curve of glucose values below 4.0 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Area under the curve of glucose values below 3.5 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Area under the curve of glucose values below 3.3 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Percentage of time of glucose levels spent above 8.0 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Percentage of time of glucose levels spent above 10.0 mmol/L [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Mean value of glucose levels [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Standard deviation of glucose levels [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Total insulin delivery [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
  • Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading [ Time Frame: 60 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dual-hormone closed-loop strategy
In dual-hormone closed-loop strategy, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
Other: 60-hours intervention
Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.
Active Comparator: Single-hormone closed-loop strategy
In single-hormone closed-loop strategy, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
Other: 60-hours intervention
Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.
Active Comparator: Conventional insulin pump therapy
In control visit, subjects will use conventional pump therapy to regulate glucose levels.
Other: 60-hours intervention
Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • HbA1c ≤ 12%.

Exclusion Criteria:

  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
  • Beta‐blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
  • Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
  • Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
  • Anticholinergic drug (risk of interaction)
  • Pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
  • Known or suspected allergy to the trial products or meal contents (gluten free menus will be available).
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting).
  • 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 meals/snacks, not willing to change pump parameters, etc).
  • Treatments that could interfere with glucagon
  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: NCT01966393

Contacts
Contact: Virginie Messier, MSc 514-987-5500 ext 3227 virginie.messier@ircm.qc.ca

Locations
Canada, Quebec
Institut de recherches cliniques de Montréal Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Virginie Messier, MSc    514-987-5500 ext 3227    virginie.messier@ircm.qc.ca   
Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD         
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD Institut de recherches cliniques de Montréal
  More Information

No publications provided

Responsible Party: Rémi Rabasa-Lhoret, Associate Professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT01966393     History of Changes
Other Study ID Numbers: CLASS-07
Study First Received: October 17, 2013
Last Updated: July 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Institut de Recherches Cliniques de Montreal:
Type 1 diabetes
Hypoglycemia
Insulin
Glucagon
Closed-loop strategy
Artificial pancreas

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 22, 2014