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

Primary Purpose

Type2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnipod 5 Automated Glucose Control System
Sponsored by
Insulet Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring T2D, Omnipod, Automated Insulin Delivery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age at time of consent 18-75 years 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) 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% Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog Participant agrees to provide their own insulin for the duration of the study Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator 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 Willing to wear the system continuously throughout the study Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol Able to read and understand English Willing and able to sign the Informed Consent Form (ICF) If female of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: Use of an AID pump in automated mode within 3 months prior to screening 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) 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 Any planned surgery during the study which could be considered major in the opinion of the investigator History of more than 1 severe hypoglycemic event in the 6 months prior to screening 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 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 Plans to receive blood transfusion over the course of the study Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 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) 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 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 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

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • Sansum Diabetes Research InstituteRecruiting
  • University of ColoradoRecruiting
  • East Coast Institute for ResearchRecruiting
  • Metabolic Research InstituteRecruiting
  • EmoryRecruiting
  • East Coast Institute for ResearchRecruiting
  • Endocrine ResearchRecruiting
  • Joslin DiabetesRecruiting
  • Henry FordRecruiting
  • Health PartnersRecruiting
  • Albert Einstein College of MedicineRecruiting
  • MAHECRecruiting
  • University of North CarolinaRecruiting
  • Physicians EastRecruiting
  • AccellaCareRecruiting
  • Ohio StateRecruiting
  • University Diabetes and Endocrine ConsultantsRecruiting
  • Texas Diabetes and EndocrinologyRecruiting
  • Diabetes and Thyroid CenterRecruiting
  • Diabetes and Glandular Disease ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All subjects wearing the Omnipod 5 Automated Glucose Monitoring System

Outcomes

Primary Outcome Measures

Change in HbA1c
The change in HbA1c at 13 weeks from baseline

Secondary Outcome Measures

Mean Glucose
Glucose metric from study provided continuous glucose monitor (CGM)
Percentage of time in range 70-180 mg/dL
Glucose metric from CGM
Percent of Time in Range 70-140 mg/dL
Glucose metric from study CGM
Percent of Time ≥ 300 mg/dL
Glucose metric from CGM
Percent of Time ≥ 250 mg/dL
Glucose metric from CGM
Percent of Time >180 mg/dL
Glucose metric from CGM
Percent of Time < 70 mg/dL
Glucose metric from CGM
Percent of Time < 54 mg/dL
Glucose metric from CGM
Change from baseline in T2-DDS 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.
Change from baseline in HCS total score
A 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.
Change from baseline in PSQI total score
Used to measure sleep disturbance and usual sleep habits
Percentage of time <70 mg/dL
Glucose metric from CGM
Percentage of time <54 mg/dL
Glucose metric from CGM
Coefficient of variation
Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)

Full Information

First Posted
March 21, 2023
Last Updated
October 9, 2023
Sponsor
Insulet Corporation
Collaborators
Jaeb Center for Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT05815342
Brief Title
OP5-005 Using Omnipod 5 in Adults With Type 2
Acronym
SECURE-T2D
Official Title
Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insulet Corporation
Collaborators
Jaeb Center for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
T2D, Omnipod, Automated Insulin Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All subjects wearing the Omnipod 5 Automated Glucose Monitoring System
Intervention Type
Device
Intervention Name(s)
Omnipod 5 Automated Glucose Control System
Intervention Description
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
The change in HbA1c at 13 weeks from baseline
Time Frame
Comparing the change in HbA1c during the 13 weeks study phase
Secondary Outcome Measure Information:
Title
Mean Glucose
Description
Glucose metric from study provided continuous glucose monitor (CGM)
Time Frame
Measuring mean glucose during the 13 weeks study phase
Title
Percentage of time in range 70-180 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Percent of Time in Range 70-140 mg/dL
Description
Glucose metric from study CGM
Time Frame
Measured during 13 weeks study phase
Title
Percent of Time ≥ 300 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Percent of Time ≥ 250 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Percent of Time >180 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Percent of Time < 70 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Percent of Time < 54 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Change from baseline in T2-DDS total score
Description
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.
Time Frame
Baseline compared to end of week 13 visit
Title
Change from baseline in HCS total score
Description
A 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.
Time Frame
Baseline compared to end week 13 visit
Title
Change from baseline in PSQI total score
Description
Used to measure sleep disturbance and usual sleep habits
Time Frame
Baseline compared to end of week 13 visit
Title
Percentage of time <70 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Percentage of time <54 mg/dL
Description
Glucose metric from CGM
Time Frame
Measured during 13 weeks study phase
Title
Coefficient of variation
Description
Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)
Time Frame
Measured during 13 weeks study phase and compared to standard therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at time of consent 18-75 years 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) 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% Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog Participant agrees to provide their own insulin for the duration of the study Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator 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 Willing to wear the system continuously throughout the study Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol Able to read and understand English Willing and able to sign the Informed Consent Form (ICF) If female of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: Use of an AID pump in automated mode within 3 months prior to screening 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) 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 Any planned surgery during the study which could be considered major in the opinion of the investigator History of more than 1 severe hypoglycemic event in the 6 months prior to screening 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 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 Plans to receive blood transfusion over the course of the study Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 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) 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trang Ly, MBBS, PhD
Phone
978-600-7000
Email
APClinical@insulet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie Dumais
Phone
978-600-7000
Email
APClinical@insulet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Pasquel, MD
Organizational Affiliation
Emory School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Walker
Email
Mawalker@usc.edu
First Name & Middle Initial & Last Name & Degree
Anne Peters, MD
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Mei Church
Phone
805-335-0504
Email
mchurch@sansum.org
First Name & Middle Initial & Last Name & Degree
Kristin Castorino, DO
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Huss
Email
Kelsey.huss@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Tamara Oser
Facility Name
East Coast Institute for Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Domingo
Email
debbie.domingo@eastcoastresearch.net
First Name & Middle Initial & Last Name & Degree
Waseem Deeb, MD
Facility Name
Metabolic Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Diazgranados
Email
sdiazgranados@metabolic-institute.com
First Name & Middle Initial & Last Name & Degree
Barry Horowitz, MD
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizda Guerrero Arroyo
Email
liguerr@emory.edu
First Name & Middle Initial & Last Name & Degree
Omolade Oladejo
Email
omolade.oladejo@emory.edu
First Name & Middle Initial & Last Name & Degree
Georgia Davis, MD
Facility Name
East Coast Institute for Research
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Alexander
Email
lindsay.alexander@eastcoastresearch.net
First Name & Middle Initial & Last Name & Degree
Jason Berner, MD
Facility Name
Endocrine Research
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Tapia
Phone
678-878-4750
Email
jtapia.ers@gmail.com
First Name & Middle Initial & Last Name & Degree
John Reed, MD
Facility Name
Joslin Diabetes
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jade Doolan
Phone
617-732-2603
Email
jade.doolan@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Lori Laffel, MD
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terra Cushman
Phone
313-916-3906
Email
Tcushma1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Davida Kruger
Facility Name
Health Partners
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Lage
Email
heather.lage@parknicollet.com
First Name & Middle Initial & Last Name & Degree
Anders Carlson
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Zavala
Email
Nathalie.zavala@einsteinmed.edu
First Name & Middle Initial & Last Name & Degree
Shivani Agarwal, MD
Facility Name
MAHEC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Duncan
Email
rachel.duncan@mahec.net
First Name & Middle Initial & Last Name & Degree
Wendy Lane, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Curlin
Email
emily_curlin@med.unc.edu
First Name & Middle Initial & Last Name & Degree
John Buse, MD
Facility Name
Physicians East
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ashley Kirk
Email
akirk@physicianseast.com
First Name & Middle Initial & Last Name & Degree
Mark Warren
Facility Name
AccellaCare
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Villa
Phone
910-815-6108
Email
karen.villa@accellacare.com
First Name & Middle Initial & Last Name & Degree
John Parker
Facility Name
Ohio State
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Aldrich
Phone
614-688-6885
Email
Lindsey.aldrich@osumc.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Dungan, MD
Facility Name
University Diabetes and Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Jones
Phone
423-558-2310
Email
mjones@drhuffman.com
First Name & Middle Initial & Last Name & Degree
David Huffman, MD
Facility Name
Texas Diabetes and Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Armstrong
Phone
512-334-3505
Email
carmstrong@tderesearch.com
First Name & Middle Initial & Last Name & Degree
Thomas Blevins, MD
Facility Name
Diabetes and Thyroid Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelsea Padilla
Phone
817-779-4478
Email
cpadilla@dtc-fw.com
First Name & Middle Initial & Last Name & Degree
Chris Bajaj
Facility Name
Diabetes and Glandular Disease Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Beltran
Email
stephanie.beltran@dgdclinic.com
First Name & Middle Initial & Last Name & Degree
Mark Kipnes, MD

12. IPD Sharing Statement

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OP5-005 Using Omnipod 5 in Adults With Type 2

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