Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02488616
• Other study ID #: CLASS-11
• Status: Withdrawn
• Phase: Phase 2
• First received: June 26, 2015
• Last updated: January 29, 2018
• Start date: March 2018
• Est. completion date: November 2018

Study information

• Verified date: January 2018
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• 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.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.

The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 = 10%.

5. Live in the area of Montreal.

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. Pregnancy (ongoing or current attempt to become pregnant).

5. Severe hypoglycemic episode within two weeks of screening.

6. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).

7. Known or suspected allergy to the trial products

8. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

9. Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• 5-day intervention with single-hormone closed-loop strategy
A sensor will be inserted on the day prior to the first day 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. Competency on the use of study devices will be assessed by a team member. 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 5 days.
• 5-day intervention with sensor-augmented pump therapy
A sensor will be inserted on the day prior to the first day 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 5 days. Participants will have been previously shown how to use the study insulin pump.

Device:
• Insulin pump
MiniMed® Paradigm® Veo™, Medtronic
• Continuous glucose monitoring system
Enlite sensor®, Medtronic

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

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 spent between 3.9 and 10.0 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent below 3.9 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent below 3.3 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent below 2.8 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent above 10 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent above 13.9 mmol/L		120 hours
Secondary	Percentage of time of glucose levels spent above 16.7 mmol/L		120 hours
Secondary	Percentage of time of overnight glucose levels spent below 3.9 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent below 3.3 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent below 2.8 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent above 10 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent above 13.9 mmol/L		35 hours
Secondary	Percentage of time of overnight glucose levels spent above 16.7 mmol/L		35 hours
Secondary	Area under the curve of glucose levels below 3.9 mmol/L		120 hours
Secondary	Area under the curve of glucose levels below 3.3 mmol/L		120 hours
Secondary	Area under the curve of glucose levels below 2.8 mmol/L		120 hours
Secondary	Area under the curve of glucose levels above 10 mmol/L		120 hours
Secondary	Area under the curve of glucose levels above 13.9 mmol/L		120 hours
Secondary	Area under the curve of glucose levels above 16.7 mmol/L		120 hours
Secondary	Area under the curve of overnight glucose levels below 3.9 mmol/L		35 hours
Secondary	Area under the curve of overnight glucose levels below 3.3 mmol/L		35 hours
Secondary	Area under the curve of overnight glucose levels below 2.8 mmol/L		35 hours
Secondary	Area under the curve of overnight glucose levels above 10 mmol/L		35 hours
Secondary	Area under the curve of overnight glucose levels above 13.9 mmol/L		35 hours
Secondary	Area under the curve of overnight glucose levels above 16.7 mmol/L		35 hours
Secondary	Mean glucose levels		120 hours
Secondary	Standard deviation of glucose levels		120 hours
Secondary	Standard deviation of insulin delivery		120 hours
Secondary	Coefficient of variance of glucose levels		120 hours
Secondary	Coefficient of variance of insulin delivery		120 hours
Secondary	Between-day variability in glucose levels		120 hours
Secondary	Between-day variability in insulin delivery		120 hours
Secondary	Total insulin delivery		120 hours
Secondary	Percentage of time of closed-loop operation		120 hours
Secondary	Percentage of time of glucose sensor availability		120 hours
Secondary	Time between failures	Total hours of closed-loop operation over number of failures	120 hours
Secondary	Number of hypoglycemic events less than 3.1 mmol/L		120 hours
Secondary	Number of nights with hypoglycemic events less than 3.1 mmol/L		35 hours
Secondary	Number of days with hypoglycemic events less than 3.1 mmol/L		120 hours