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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966393
• Other study ID #: CLASS-07
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2013
• Last updated: May 1, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.	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.	60 hours	No
Secondary	Percentage of time of glucose levels spent below 3.5 mmol/L		60 hours	No
Secondary	Percentage of time of glucose levels spent below 3.3 mmol/L		60 hours	No
Secondary	Area under the curve of glucose values below 4.0 mmol/L		60 hours	No
Secondary	Area under the curve of glucose values below 3.5 mmol/L		60 hours	No
Secondary	Area under the curve of glucose values below 3.3 mmol/L		60 hours	No
Secondary	Percentage of time of glucose levels spent above 8.0 mmol/L		60 hours	No
Secondary	Percentage of time of glucose levels spent above 10.0 mmol/L		60 hours	No
Secondary	Mean value of glucose levels		60 hours	No
Secondary	Standard deviation of glucose levels		60 hours	No
Secondary	Total insulin delivery		60 hours	No
Secondary	Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading		60 hours	No