Prepivotal Omnipod Horizon™ Automated Glucose Control System

NCT04176731 | Completed Results DMC FDA Device

• 1 other identifier: Horizon™ Prepivotal Study
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief Summary

Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.

Conditions

Type 1 Diabetes Mellitus

Keywords

T1D; Omnipod

Outcome Measures

Primary Outcomes (5)

• Proportion of Subjects With Severe Hypoglycemia

  Measure of serious device-related adverse events

  hybrid closed-loop (14 days)

• Proportion of Subjects With Diabetic Ketoacidosis (DKA)

  Measure of serious device-related adverse events

  hybrid closed-loop (14 days)

• Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)

  Percentage of time in range 70-180 mg/dL

  hybrid closed-loop (9 days) compared to standard therapy (14 days)

• Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)

  Percentage of time in range 70-180 mg/dL

  hybrid closed-loop (5 days) compared to standard therapy (14 days)

• Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)

  Percentage of time in range 70-180 mg/dL

  hybrid closed-loop (14 days) compared to standard therapy (14 days)

Secondary Outcomes (15)

• Mean Glucose

  hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall

• Time in Range 70-180 mg/dL

  hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall

• Time in Range 70-140 mg/dL

  hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall

• Percentage of Time >180 mg/dL

  hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall

• Percentage of Time ≥250 mg/dL

  hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm

Device: Omnipod Horizon™ Automated Glucose Control System

Interventions

Omnipod Horizon™ Automated Glucose Control System DEVICE

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Treatment

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of consent/assent 6-70 years
• Subjects aged \< 18 years must be living with parent/legal guardian
• Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
• Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
• Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog, or Apidra during the study
• Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase
• Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria
• Willing to wear the system continuously throughout the study
• A1C \<10% at screening visit
• Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
• Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
• Able to read and speak English fluently
• Subject must be in an AT\&T covered area
• 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 aged \< 18 years per State requirements.

You may not qualify if:

• A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
• History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months
• History of DKA (as defined in Section 11.3.4) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
• Diagnosed with sickle cell disease
• Diagnosed with hemophilia or any other bleeding disorders
• Plans to receive blood transfusion over the course of the study
• Currently diagnosed with anorexia nervosa or bulimia
• Acute or chronic kidney disease (e.g. estimated GFR \< 45) or currently on hemodialysis
• History of adrenal insufficiency
• Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the course of the study
• Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
• Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
• 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.
• For subjects \>50 years old or with diabetes duration \>20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (\> 450 ms)

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (6)

Stanford University

Palo Alto, California, 94305, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Trang Ly
• Organization: Insulet Corporation

tly@insulet.com

9786007628

Study Officials

• Bruce Buckingham, MD

  Stanford University

  STUDY CHAIR

• Sue Brown, MD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, multi-center, prospective clinical study.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 25, 2019
• Study Start: December 15, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)