OP5-005 Using Omnipod 5 in Adults With Type 2 (SECURE-T2D)

Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes

This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Device: Omnipod 5 Automated Glucose Control System

Detailed Description

This outpatient study consists of 2 phases.

Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information.

Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

• Study Type: Interventional
• Enrollment (Actual): 343
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90022
      • University of Southern California
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory
    • Canton, Georgia, United States, 30114
      • East Coast Institute for Research
    • Roswell, Georgia, United States, 30076
      • Endocrine Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Health Partners
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • MAHEC
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • Ohio
    • Columbus, Ohio, United States, 43203
      • Ohio State
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • University Diabetes and Endocrine Consultants
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Center
    • San Antonio, Texas, United States, 78229
      • Diabetes and Glandular Disease Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age at time of consent 18-75 years
2. Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix)
3. Basal bolus (long-acting insulin and rapid acting analog) or pre-mix users with A1C <12.0% OR basal users on long or intermediate acting insulin only with A1C > 7.0% and < 12.0%
4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
5. Participant agrees to provide their own insulin for the duration of the study
6. Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
7. Stable doses of weight loss medications over the preceding 4 weeks and throughout the study that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, as determined by Investigator
8. Willing to wear the system continuously throughout the study
9. Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
11. Able to read and understand English or Spanish
12. Willing and able to sign the Informed Consent Form (ICF)
13. If female of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

1. Use of an AID pump in automated mode within 3 months prior to screening
2. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
3. 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 12 months prior to screening
4. Any planned surgery during the study which could be considered major in the opinion of the investigator
5. History of more than 1 severe hypoglycemic event in the 6 months prior to screening
6. History of more than 1 episode of diabetic ketoacidosis (DKA) or Hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis
7. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1c
8. Plans to receive blood transfusion over the course of the study
9. Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study
10. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
11. Pregnant or lactating, planning to become pregnant during the study, 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); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
12. Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period
13. 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
14. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All subjects wearing the Omnipod 5 Automated Glucose Monitoring System	Device: Omnipod 5 Automated Glucose Control System; The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	The change in HbA1c at 13 weeks from baseline	Comparing the change in HbA1c during the 13 weeks study phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Glucose	Glucose metric from study provided continuous glucose monitor (CGM)	Measuring mean glucose during the 13 weeks study phase
Percentage of time in range 70-180 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percent of Time in Range 70-140 mg/dL	Glucose metric from study CGM	Measured during 13 weeks study phase
Percent of Time ≥ 300 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percent of Time ≥ 250 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percent of Time >180 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percent of Time < 70 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percent of Time < 54 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percentage of time <70 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Percentage of time <54 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Coefficient of variation	Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)	Measured during 13 weeks study phase and compared to standard therapy
Change from baseline in T2-DDAS total score	A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.	Baseline compared to end of week 13 visit
% Meeting MCID for T2-DDAS	A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.	Baseline compared to end week 13 visit
Change from baseline in PSQI total score	Change from baseline in PSQI total score	Baseline compared to end of week 13 visit
% Meeting MCID for PSQI	Change from baseline in PSQI total score	Baseline compared to end of week 13 visit
Change from baseline in HCS total score	Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.	Baseline compared to end week 13 visit
% Meeting MCID for HCS	Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.	Baseline compared to end week 13 visit

Collaborators and Investigators

• Sponsor: Insulet Corporation
• Collaborators: Jaeb Center for Health Research
• Investigators: Study Chair: Francisco J Pasquel, MD, Emory School Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: T2D; Automated Insulin Delivery; Omnipod
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: G230013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes