Assessment of an Automatic Closed-loop Insulin Delivery System

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Assessment of an Automatic Closed-loop Insulin Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366767
• Other study ID #: G140095
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2014
• Last updated: February 11, 2015
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The overall aim of this research proposal is to determine the safety, feasibility and efficacy of an automatic closed-loop insulin delivery system.

Description:

This study will be completed in two parts.

The initial part of this study will be an inpatient evaluation of the system with the primary goal of assessing safety and feasibility. This will involve 8 subjects with type 1 diabetes, aged 14 - 40 years, admitted for up to 60 hour. Plasma glucose levels will be collected hourly and tested by YSI (YSI 2300, Yellow Springs Instrument). These studies will be performed at Stanford University and will include group sporting activities to mimic the diabetes camp environment. Capillary blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise, and prebed by subjects with research staff supervision during the day and at 00:00, 03:00 and 07:00 by research staff. These data will be reviewed by the DSMB before proceeding to camp studies.

The second part of this study will be to test the efficacy of the system during diabetes summer camps. We will test the system in subjects with type 1 diabetes, aged 14-40 years, attending diabetes camp. There will be 20 subjects recruited, with 10 subjects randomized to the control arm Medtronic 530G system with threshold suspend (control group) and 10 subjects randomized to the automatic closed-loop insulin delivery (intervention group). Capillary blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise and prebed by subjects with research staff supervision and at 00:00, 03:00 and 07:00 by research staff. The primary aim of this study is to generate preliminary data of system safety and efficacy in a closely supervised environment that challenges glucose control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes

• The diagnosis of type 1 diabetes is based on the investigator's judgment

• C peptide levels and antibody determinations are not required

2. Daily insulin therapy for = 12 months

3. Insulin pump therapy for = 3 months

4. Age 14.0 - 40.0 years

5. Subject comprehends written English

6. Female subjects who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD

7. Female subjects past menarche must have a negative urine pregnancy test

8. Informed consent form is signed by the subject and/or parent and assent assigned by the subject if under 18 years of age

9. For subjects under 18 years, both the subject and parent/guardian understand the study protocol and agree to comply with it. Both parents must sign if possible.

Exclusion Criteria:

1. Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol

2. Diabetic ketoacidosis in the past month

3. Hypoglycemic seizure or loss of consciousness or an event requiring glucagon or IV glucose in the past 3 months

4. Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis

5. Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease

6. Subject has a history of liver or kidney disease (other than microalbuminuria)

7. Subject has active Graves' disease

8. Subjects with inadequately treated thyroid disease or celiac disease

9. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol

10. Subject has a history of diagnosed medical eating disorder

11. Subject has a history of known illicit drug abuse

12. Subject has a history of known prescription drug abuse

13. Subject has a history of current alcohol abuse

14. Subject has a history of visual impairment which would not allow subject to participate

15. Subject has an active skin condition that would affect sensor placement

16. Subject has adhesive allergies

17. Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)

18. Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)

19. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study

20. Subject is currently on beta blocker medication

21. Subject is currently participating in another investigational study (drug or device)

22. Subject is deemed by the investigator to be unwilling or unable to follow the protocol

23. Presence of a febrile illness within 24 hours of enrollment

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Automatic closed-loop insulin delivery
Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes.
• Control
Threshold suspend

Locations

Country	Name	City	State
United States	Camp Conrad-Chinnock	Angelus Oaks	California
United States	Packard El Camino Hospital	Mountain View	California
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of automatic closed loop insulin delivery system adolescents and adults with type 1 diabetes	Plasma glucose values remain = 50 mg/dL during closed-loop control OR system alerts precede a plasma glucose value of = 50 mg/dL in all subjects; System alerts precede plasma glucose values > 300 mg/dL for more than one hour, in all subjects.; Subjects do not experience serum ketones >3 mmol/L during closed-loop control.; There are no events of severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose during closed-loop control.	June-Aug 2014	Yes
Secondary	To evaluate the automatic closed loop delivery system in adolescents and adults with type 1 diabetes	The system can be initiated and operational for at least 75% of the time for 75% of subjects.; Study enrollment procedures and education on the system can occur within 2 hours for 75% of the subjects.	June-Aug 2014	No