Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 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 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846831
• Other study ID #: CLASS-14
• Status: Completed
• Phase: Phase 2
• Start date: January 24, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: June 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• 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 = 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)

Related Conditions & MeSH terms

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

Intervention

Other:
• 12-day intervention with sensor-augmented pump therapy
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 strategy
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.

Device:
• Insulin pump
Tandem Diabetes Care
• Continuous glucose monitoring system
Dexcom G5 Platinum

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
Canada	McGill University Health Centre	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 mmol/L.		288 hours
Secondary	Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L		288 hours
Secondary	Percentage of time of glucose levels spent below 3.9 mmol/L		288 hours
Secondary	Percentage of time of glucose levels spent below 3.3 mmol/L		288 hours
Secondary	Percentage of time of glucose levels spent below 2.8 mmol/L		288 hours
Secondary	Percentage of time of glucose levels spent above 10.0 mmol/L		288 hours
Secondary	Percentage of time of glucose levels spent above 13.9 mmol/L		288 hours
Secondary	Percentage of time of glucose levels spent above 16.7 mmol/L		288 hours
Secondary	Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent below 3.9 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent below 3.3 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent below 2.8 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent above 10.0 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent above 13.9 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Percentage of time of overnight glucose levels spent above 16.7 mmol/L	The overnight period is between 00:00 and 06:00	72 hours
Secondary	Total number of hypoglycemic events below 3.1 mmol/L		288 hours
Secondary	Number of nights with hypoglycemic events below 3.1 mmol/L		72 hours
Secondary	Number of days with hypoglycemic events below 3.1 mmol/L		126 hours
Secondary	Mean glucose levels		288 hours
Secondary	Standard deviation of glucose levels		288 hours
Secondary	Time between failures due to glucose sensor unavailability		288 hours
Secondary	Coefficient of variation of glucose levels		288 hours
Secondary	Between-day variability in glucose levels		288 hours
Secondary	Total daily insulin dose		24 hours
Secondary	Standard deviation of insulin delivery		288 hours
Secondary	Coefficient of variation of insulin delivery		288 hours
Secondary	Between-day variability in insulin delivery		288 hours
Secondary	Total number of hours of glucose sensor availability		288 hours
Secondary	Percentage of time of glucose sensor availability		288 hours
Secondary	Time between failures due to pump connectivity		288 hours
Secondary	Percentage of time when patients switched back to insulin pump therapy		288 hours
Secondary	Number of hours when patients switched back to insulin pump therapy		288 hours
Secondary	Percentage of time when the closed-loop was automatically switched to insulin pump therapy		288 hours
Secondary	Number of hours when the closed-loop was automatically switched to insulin pump therapy		288 hours
Secondary	Number of days with at least one technical problem		288 hours
Secondary	Number of calls for technical issues related to the closed-loop system		288 hours
Secondary	Number of patients calling for technical issues related to the closed-loop system		288 hours