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

NCT01966393 | Completed Phase 2

• 1 other identifier: CLASS-07
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Hypoglycemia; Insulin; Glucagon; Closed-loop strategy; Artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.

  Hypoglycemic range is defined to be between below 4 mmol/L

  60 hours

Secondary Outcomes (12)

• Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.

  60 hours

• Percentage of time of glucose levels spent below 3.5 mmol/L

  60 hours

• Percentage of time of glucose levels spent below 3.3 mmol/L

  60 hours

• Area under the curve of glucose values below 4.0 mmol/L

  60 hours

• Area under the curve of glucose values below 3.5 mmol/L

  60 hours

Study Arms (3)

Dual-hormone closed-loop strategy

ACTIVE COMPARATOR

In dual-hormone closed-loop strategy, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels

Other: 60-hours intervention

Single-hormone closed-loop strategy

ACTIVE COMPARATOR

In single-hormone closed-loop strategy, variable subcutaneous insulin infusion rate will be used to regulate glucose levels

Other: 60-hours intervention

Conventional insulin pump therapy

ACTIVE COMPARATOR

In control visit, subjects will use conventional pump therapy to regulate glucose levels.

Other: 60-hours intervention

Interventions

60-hours intervention OTHER

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.

Conventional insulin pump therapy; Dual-hormone closed-loop strategy; Single-hormone closed-loop strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 21, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 4, 2015

Record last verified: 2015-05

Locations

CA (1)