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Type2 DiabetesSECURE-T2DNCT05815342

OP5-005 Using Omnipod 5 in Adults With Type 2

A study of Type2 Diabetes, run by Insulet Corporation at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type2 Diabetes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
343 participants
Where
21 sitesUnited States
Study dates
11 Apr 2023to 1 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 or Spanish
  • Willing and able to sign the Informed Consent Form (ICF)
  • If female of childbearing potential, willing and able to have pregnancy testing

Who cannot join

  • 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
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  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • MAHEC

    Asheville, North Carolina, 28803

  • Emory

    Atlanta, Georgia, 30303

  • University of Colorado

    Aurora, Colorado, 80045

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731

  • Joslin Diabetes

    Boston, Massachusetts, 02215

  • East Coast Institute for Research

    Canton, Georgia, 30114

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Ohio State

    Columbus, Ohio, 43203

  • Henry Ford

    Detroit, Michigan, 48202

  • Diabetes and Thyroid Center

    Fort Worth, Texas, 76132

  • Physicians East

    Greenville, North Carolina, 27834

  • East Coast Institute for Research

    Jacksonville, Florida, 32216

  • University of Southern California

    Los Angeles, California, 90022

  • Health Partners

    Minneapolis, Minnesota, 55416

  • Endocrine Research

    Roswell, Georgia, 30076

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

  • AccellaCare

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Type2 Diabetes
Being tested
Omnipod 5 Automated Glucose Control System
Keywords
T2D, Omnipod, Automated Insulin Delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omnipod 5 Automated Glucose Control SystemDevice

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

Study groups in NCT05815342
Study groupRoleWhat they receive
TreatmentExperimentalAll subjects wearing the Omnipod 5 Automated Glucose Monitoring System
Receives: Device: Omnipod 5 Automated Glucose Control System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    The change in HbA1c at 13 weeks from baseline

    Measured: Comparing the change in HbA1c during the 13 weeks study phase

Secondary outcomes (17)

  1. Mean Glucose

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: Measuring mean glucose during the 13 weeks study phase

  2. Percentage of Time in Range 70-180 mg/dL

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  3. Percent of Time in Range 70-140 mg/dL

    Glucose metric from study CGM

    Measured: Measured during 13 weeks study phase

  4. Percent of Time ≥ 300 mg/dL

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  5. Percent of Time > 250 mg/dL

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  6. Percent of Time >180 mg/dL

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  7. Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%]

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  8. Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%]

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  9. 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.

    Measured: Baseline compared to end of week 13 visit

  10. Percentage 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.

    Measured: Baseline compared to end week 13 visit

  11. Change From Baseline in Pittsburgh Sleep Quality Index Total Score

    Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.

    Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality).

    Measured: Baseline compared to end of week 13 visit

  12. % Meeting MCID for Pittsburgh Sleep Quality Index

    Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.

    Measured: Baseline compared to end of week 13 visit

  13. 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.

    Measured: Baseline compared to end week 13 visit

  14. % 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.

    Measured: Baseline compared to end week 13 visit

  15. Percentage of Time <70 mg/dL (Superiority)

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  16. Percentage of Time <54 mg/dL (Superiority)

    Glucose metric from CGM

    Measured: Measured during 13 weeks study phase

  17. Coefficient of Variation

    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.

    Measured: Measured during 13 weeks study phase and compared to standard therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start11 Apr 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05815342
Sponsor's protocol ID
G230013
Acronym
SECURE-T2D
Status last verified
Sep 2025
First submitted
21 Mar 2023
Last updated
29 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Pasquel FJ, Davis GM, Huffman DM, Peters AL, Parker JC, Laffel LM, Romeo GR, Mathew J, Castorino KN, Kruger DF, Dungan KM, Kipnes M, Jauch EC, Oser TK, Shah VN, Horowitz B, Carlson AL, Warren ML, Deeb W, Buse JB, Reed JH, Berner J, Blevins T, Bajaj C, Kollman C, Raghinaru D, Ly TT, Beck RW; Omnipod 5 SECURE-T2D Consortium. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459348. doi: 10.1001/jamanetworkopen.2024.59348.

    PubMed 39951268

Questions about this trial

What is this clinical trial studying?

A study of Type2 Diabetes, run by Insulet Corporation at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Comparing the change in HbA1c during the 13 weeks study phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05815342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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