Insulet Artificial Pancreas Early Feasibility Study

Type 1 Diabetes Clinical Trial

Official title:

A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897557
• Other study ID #: AP-IDE #1 and 1a
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2021
• Source: Insulet Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

1. Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years

2. Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.

3. Total daily dose (TDD) of insulin = 0.3 units/kg/day and A1C > 6% at screening

4. Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump for at least 6 months prior to start of study

5. Willing to use the study CGM device for one week prior to study start and for the duration of the study

6. Willing to use the OmniPod® Insulin Management System during the study

7. Willing to perform all SMBG testing with the study-approved glucose meter at the frequency specified in the study protocol

8. Willing to abide by meal recommendations for breakfast, lunch and dinner during the study

9. Willing to refrain from use of acetaminophen, pseudoephedrine, and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study

10. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. Subjects aged = 8 years will be asked to sign an assent form.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. A1c >10% at the Screening visit

2. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months

3. Hypoglycemic unawareness as determined by a score of 4 or more "R" responses on the Clarke Questionnaire

4. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months

5. Used non-insulin anti-diabetic medication within last 30 days

6. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)

7. Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor on the abdomen

8. Known history of myocardial infarction (MI) or stroke within the past 6 months

9. Known history of seizure disorder

10. Known history of adrenal insufficiency

11. Current renal or hepatic disease

12. Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)

13. Currently undergoing cancer treatment

14. Currently undergoing systemic treatment with steroids or immunosuppressive medication

15. History of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants

16. Current illness that would interfere with participation in the study

17. Untreated or inadequately treated mental illness

18. Current alcohol abuse per investigator's judgment

19. Electrically-powered implants that may be susceptible to RF interference

20. Currently participating in another clinical study testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days

21. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Insulet Artificial Pancreas (AP) System

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado
United States	Stanford University	Palo Alto	California
United States	William Sansum Diabetes Center	Santa Barbara	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Insulet Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time in hypoglycemic range (defined as <70 mg/dL)		36 hours
Primary	Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)		36 hours
Secondary	Mean glucose		36 hours
Secondary	Percentage of time < 50 mg/dL		36 hours
Secondary	Percentage of time < 60 mg/dL		36 hours
Secondary	Percentage of time > 180 mg/dL		36 hours
Secondary	Percentage of time >/= 300 mg/dL		36 hours
Secondary	Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)		36 hours
Secondary	Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)		36 hours
Secondary	Standard deviation and coefficient of variation of CGM values		36 hours