Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)

Type 1 Diabetes Mellitus Clinical Trial

— IDE2  

Official title:

Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064906
• Other study ID #: IDE2
• Status: Completed
• Phase: N/A
• Start date: March 18, 2017
• Est. completion date: April 7, 2017

Study information

• Verified date: June 2018
• Source: Insulet Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.

Description:

The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 7, 2017
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age at time of consent 18.0 to 65.0 years

2. Diagnosed with type 1 diabetes for at least one 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 therapy for at least 6 months prior to study start

5. Willing to use the study CGM device for the duration of the study

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

7. Willing to perform all fingerstick BG 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 participate in moderate intensity exercise for up to 45 minutes if taking part in Option B

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

11. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

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 "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

8. Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.

9. Currently undergoing systemic treatment with steroids or immunosuppressive medication

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

11. Currently participating in another clinical study using an investigational drug or device

12. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.

Related Conditions & MeSH terms

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

Intervention

Device:
• Insulet AP (artificial pancreas) System
Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado
United States	Stanford University	Palo Alto	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)		54 hours
Primary	Percentage of time in hyperglycemic range(defined as = 250 mg/dL)		54 hours
Secondary	Mean glucose		54 hours
Secondary	Percentage of time < 50 mg/dL		54 hours
Secondary	Percentage of time < 60 mg/dL		54 hours
Secondary	Percentage of time > 180 mg/dL		54 hours
Secondary	Percentage of time = 300 mg/dL		54 hours
Secondary	Percentage of time between 70-180 mg/dL		54 hours
Secondary	Percentage of time between 70-140 mg/dL		54 hours
Secondary	Standard deviation		54 hours
Secondary	Coefficient of variation		54 hours
Secondary	Meal challenge-12 hour PPG dinner	The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner.	54 hours
Secondary	Meal challenge-4 hour PPG breakfast	The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast.	54 hours
Secondary	Meal challenge-4 hour PPG lunch	The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch.	54 hour
Secondary	Exercise challenge-immediate and delayed glucose response	The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise.	54 hour
Secondary	Effect of changing setpoints	Effect of changing setpoints to overall performance.	54 hour