Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes

Institut de Recherches Cliniques de Montreal36 enrolled

Overview

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. The objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings. The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

A sensor will be inserted on the day before the start of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 12 days. Participants will have been previously shown how to use the study insulin pump.

12-day intervention with single-hormone closed-loop strategyOTHER

A sensor will be inserted on the day before the start of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 12 days.

Insulin pumpDEVICE

Tandem Diabetes Care

Continuous glucose monitoring systemDEVICE

Dexcom G5 Platinum

InsulinDRUG

Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females ≥ 18 years of old. 2. Clinical diagnosis of type 1 diabetes for at least one year. 3. The subject will have been on insulin pump therapy for at least 3 months. 4. HbA1c ≤ 12%. Exclusion Criteria: 1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator 2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery 3. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding) 4. Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings 5. Pregnancy (ongoing or current attempt to become pregnant) 6. Breastfeeding 7. No nearby party for assistance if needed 8. Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period 9. Severe hypoglycemic episode within two weeks of screening or during the run-in period 10. Severe hyperglycemic episode requiring hospitalization in the last 3 months 11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids) 12. Known or suspected allergy to the trial products 13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator 14. Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)

Locations (2)

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.

Time frame: 288 hours

Secondary Outcomes

Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Time frame: 288 hours

Percentage of time of glucose levels spent below 3.9 mmol/L

Time frame: 288 hours

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

Time frame: 288 hours

Percentage of time of glucose levels spent below 2.8 mmol/L

Time frame: 288 hours

Percentage of time of glucose levels spent above 10.0 mmol/L

Time frame: 288 hours

Percentage of time of glucose levels spent above 13.9 mmol/L

Time frame: 288 hours

Percentage of time of glucose levels spent above 16.7 mmol/L

Time frame: 288 hours

Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L