Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

An Open-label, Randomized, Multicenter Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 15 Weeks in Free-living Outpatient Conditions in Adolescents and Adults With Type 1 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02846857
• Other study ID #: CLASS-17
• Status: Withdrawn
• Phase: Phase 2

Study information

• Verified date: July 2019
• 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. A dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon.

The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults.

The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Males and females = 12 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 = 11%.

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. History of pheochromocytoma or insulinoma (glucagon could induce a hormonal response of these tumors)

4. 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)

5. Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)

6. Chronic acetaminophen treatment (can interfere with glucose sensor measurements)

7. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)

8. Anticholinergic drug (risk of interaction)

9. Pregnancy.

10. Severe hypoglycemic episode within two weeks of screening.

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

15. Treatments that could interfere with glucagon

Related Conditions & MeSH terms

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

Intervention

Other:
• 15-week intervention with sensor-augmented pump
A sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks. Participants will have been previously shown how to use the study insulin pump.
• 15-week intervention with single-hormone closed-loop
A sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks.
• 15-week intervention with dual-hormone closed-loop
A sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks. Participants will have to reconstitute glucagon everyday.

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)
• Glucagon
Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time of glucose levels below 3.9 mmol/L		15 weeks
Secondary	HbA1c		15 weeks
Secondary	Percentage of time of glucose levels spent in the target range	Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 7.8 mmol/L from 22:00 to 7:00	15 weeks
Secondary	Area under the curve of glucose levels below 3.9 mmol/L		15 weeks
Secondary	Area under the curve of glucose levels below 3.3 mmol/L		15 weeks
Secondary	Area under the curve of glucose levels below 2.8 mmol/L		15 weeks
Secondary	Percentage of time of glucose levels below 3.3 mmol/L		15 weeks
Secondary	Percentage of time of glucose levels below 2.8 mmol/L		15 weeks
Secondary	Total number of hypoglycemic events below 3.1 mmol/L		15 weeks
Secondary	Percentage of time of glucose levels above 7.8 mmol/L		15 weeks
Secondary	Percentage of time of glucose levels above 10.0 mmol/L		15 weeks
Secondary	Mean glucose levels		15 weeks
Secondary	Standard deviation of glucose levels		15 weeks
Secondary	Coefficient of variation of glucose levels		15 weeks
Secondary	Total daily dose of insulin		24 hours
Secondary	Total daily dose of glucagon		24 hours
Secondary	Percentage of time of closed-loop operation		15 weeks
Secondary	Percentage of time of glucose sensor availability		15 weeks
Secondary	Time between failures due to glucose sensor unavailability		15 weeks
Secondary	Time between failures due to pump connectivity		15 weeks
Secondary	Percentage of time when patients switched back to insulin pump therapy		15 weeks
Secondary	Percentage of time when the closed-loop was automatically switched to insulin pump therapy		15 weeks