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Insulet Artificial Pancreas Free-Living IDE3

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ClinicalTrials.gov Identifier: NCT03216460
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Insulet Corporation

Brief Summary:
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Device: Insulet automated glucose control system Not Applicable

Detailed Description:

The study schedule will consist of a standard therapy data collection week followed by a hybrid closed-loop phase.

Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

The hybrid closed-loop phase will begin prior to lunch on Study Day 1.

During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise.

Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a single-arm, multi-center, observational clinical study.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Supervised Free-Living
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting, where subjects will participate in specific setpoint challenges, meal challenges, and exercise
Device: Insulet automated glucose control system
Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.




Primary Outcome Measures :
  1. Percentage of time in hypoglycemic range (defined as < 70 mg/dL) [ Time Frame: 96 hours ]
  2. Percentage of time in hyperglycemic range (defined as ≥ 250 mg/dL) [ Time Frame: 96 hours ]

Secondary Outcome Measures :
  1. Mean Glucose [ Time Frame: 96 hours ]
  2. Percentage of time < 50 mg/dL [ Time Frame: 96 hours ]
  3. Percentage of time < 54 mg/dL [ Time Frame: 96 hours ]
  4. Percentage of time < 60 mg/dL [ Time Frame: 96 hours ]
  5. Percentage of time > 180 mg/dL [ Time Frame: 96 hours ]
  6. Percentage of time ≥ 300 mg/dL [ Time Frame: 96 hours ]
  7. Percentage of time between 70-180 mg/dL [ Time Frame: 96 hours ]
  8. Percentage of time between 70-140 mg/dL [ Time Frame: 96 hours ]
  9. Standard deviation [ Time Frame: 96 hours ]
    Using CGM measurements, the Standard deviations will be reported for the entire hybrid closed-loop phase overall, as well as separately during the day (0700 - 2259h) and during the night (2300 - 0659h).

  10. Coefficient of variation [ Time Frame: 96 hours ]
    Using CGM measurements, the Coefficient of variation will be reported for the entire hybrid closed-loop phase overall, as well as separately during the day (0700 - 2259h) and during the night (2300 - 0659h).



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.


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Ages Eligible for Study:   2 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at time of consent 2.0-85 years
  2. Individuals aged ≥6.0 must be diagnosed with type 1 diabetes for at least one year. Preschool children aged 2.0-5.9 years must be diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
  3. A1C <10% at screening
  4. Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 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 or per investigator discretion
  8. Willing to participate in setpoint and meal challenges
  9. Willing to use carbohydrate counting for determination of meal boluses
  10. Willing to participate in moderate intensity exercise for at least 30 minutes per day
  11. Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
  12. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects per State requirements.

Exclusion Criteria:

  1. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
  2. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
  3. Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
  4. Using a basal insulin with a usual duration of insulin action > 36 hours
  5. 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)
  6. Dermatological conditions at the proposed sensor/pump wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
  7. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. Abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QT interval (> 440 ms). Electrocardiogram is only required for subjects >50 years old or with diabetes duration >20 years.
  8. Stroke
  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. Known 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 using an investigational drug or device
  21. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug
  22. Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.

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): NCT03216460


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Insulet Corporation
Investigators
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Principal Investigator: Bruce Buckingham, MD Stanford University

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Responsible Party: Insulet Corporation
ClinicalTrials.gov Identifier: NCT03216460     History of Changes
Other Study ID Numbers: IDE3
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Insulet Corporation:
T1D, Omnipod
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Gastrointestinal Agents