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Insulet Artificial Pancreas Free-Living IDE3

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ClinicalTrials.gov Identifier: NCT03216460
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : June 20, 2018
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 hybrid closed-loop, subjects will be encouraged to eat regular meals and to perform exercise each day. Adolescents and children will not leave the facility unsupervised, however adult subjects will be able to leave the facility for several hours per day in between meal boluses. There will be remote monitoring capabilities for technical and glucose alerts.

After the initial 48 hours of closed-loop (except children ages 2.0-5.9 years), system delivered basal insulin will be reviewed and basal rates may be updated by the investigator per protocol to test controller performance pre and post updates.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : July 11, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

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 be encouraged to eat regular meals and to perform exercise each day.
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

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at time of consent ≥ 2 years and < 65 years
  2. Individuals ages 6.0 to < 65.0 must be diagnosed with type 1 diabetes for at least one year. Children ages 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 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. Using carbohydrate counting for determination of meal boluses
  9. Willing to participate in exercise for at least 30 minutes per day
  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) and/or has a parent or guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged ≥ 8 years.

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 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 cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke.
  8. Known history of seizure disorder
  9. Known history of adrenal insufficiency
  10. Current renal or hepatic disease
  11. Untreated or unstable hypothyroidism or celiac disease (per investigator's 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


Contacts
Contact: Trang Ly, MBBS (978) 600-7000 APClinical@insulet.com
Contact: Bonnie Dumais, RN (978) 600-7708 APClinical@insulet.com

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Bruce Buckingham, MD       bbendo@stanford.edu   
Contact: Liana Hsu    (650) 725-3939    ljhsu@stanford.edu   
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Gregory Forlenza, MD       gregory.forlenza@ucdenver.edu   
Contact: Katelin Thivener    (303) 724-9998    katelin.thivener@ucdenver.com   
United States, Connecticut
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Jennifer Sherr, MD, PhD       jennifer.sherr@yale.edu   
Contact: Lori Carria, MS    (203) 737-3595    lori.carria@yale.edu   
Sponsors and Collaborators
Insulet Corporation
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University

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: June 20, 2018
Last Verified: June 2018
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: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Insulet Corporation:
T1D, Omnipod

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