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Insulet Artificial Pancreas Early Feasibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02897557
First Posted: September 13, 2016
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Insulet Corporation
  Purpose
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.

Condition Intervention
Type 1 Diabetes Device: Insulet Artificial Pancreas (AP) System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Insulet Corporation:

Primary Outcome Measures:
  • Percentage of time in hypoglycemic range (defined as <70 mg/dL) [ Time Frame: 36 hours ]
  • Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL) [ Time Frame: 36 hours ]

Secondary Outcome Measures:
  • Mean glucose [ Time Frame: 36 hours ]
  • Percentage of time < 50 mg/dL [ Time Frame: 36 hours ]
  • Percentage of time < 60 mg/dL [ Time Frame: 36 hours ]
  • Percentage of time > 180 mg/dL [ Time Frame: 36 hours ]
  • Percentage of time >/= 300 mg/dL [ Time Frame: 36 hours ]
  • Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL) [ Time Frame: 36 hours ]
  • Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL) [ Time Frame: 36 hours ]
  • Standard deviation and coefficient of variation of CGM values [ Time Frame: 36 hours ]

Enrollment: 59
Actual Study Start Date: September 2016
Study Completion Date: March 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Cohort in CRC
This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.
Device: Insulet Artificial Pancreas (AP) System

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897557


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
Sponsors and Collaborators
Insulet Corporation
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
  More Information

Responsible Party: Insulet Corporation
ClinicalTrials.gov Identifier: NCT02897557     History of Changes
Other Study ID Numbers: AP-IDE #1 and 1a
First Submitted: September 1, 2016
First Posted: September 13, 2016
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents