Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Insulet Corporation
Study ID
NCT07521475
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Device: Omnipod M System with study CGM — DEVICE
    The Omnipod M system with the study CGM
  • Standard Therapy plus study CGM — DEVICE
    Standard therapy is continuation of pre-study insulin regimen and study CGM.

Study Details

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Dec 24, 2026
Completion
Sep 23, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group - Omnipod M
    The Intervention group will be assigned the Omnipod M system with the study CGM
  • Active Comparator: Control group - Pre-study insulin regimen
    The control group will continue the use of pre-study insulin regimen with the study CGM.

Primary Outcome Measure

HbA1c [ Time Frame: 15 and 26 weeks ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105
Maggie Shuiman
[email protected]
(805) 350-8941
Kristin Castorino (PRINCIPAL_INVESTIGATOR)
Touro University CaliforniaVallejoCalifornia94592
Tess Calinawan
[email protected]
(707) 638-5969
Jay Shubrook (PRINCIPAL_INVESTIGATOR)
University of Colorado DenverDenverColorado80204
Cari Berget
[email protected]
(303) 742-8377
Erik Kramer (PRINCIPAL_INVESTIGATOR)
Metabolic Research InstituteWest Palm BeachFlorida33401
Amanda Calderon
[email protected]
(561) 802-3060
Barry Horowitz (PRINCIPAL_INVESTIGATOR)
Atlanta Diabetes AssociatesAtlantaGeorgia30318
Amanda Maxson
[email protected]
(404) 355-4393
Bruce Bode (PRINCIPAL_INVESTIGATOR)
Endocrine Research Solutions, Inc.RosewellGeorgia30076
Jessica Tapia
[email protected]
(678) 878-4750
John Reed (PRINCIPAL_INVESTIGATOR)
Rocky Mountain DiabetesIdaho FallsIdaho83404
Joann Malone
[email protected]
(208) 528-9650
David Liljenquist (PRINCIPAL_INVESTIGATOR)
Henry Ford HealthDetroitMichigan48202
Lydia Oehring
[email protected]
(313) 916-3906
Davida Kruger (PRINCIPAL_INVESTIGATOR)
SUNY SyracuseSyracuseNew York13210
Suzan Bzdick
[email protected]
(315) 464-9006
Malek El Muayed (PRINCIPAL_INVESTIGATOR)
Mountain Area Health Education CenterAshevilleNorth Carolina28803
Michelle Chapman
[email protected]
(828) 708-8281
Casey Wells (PRINCIPAL_INVESTIGATOR)
University of Diabetes and Endocrine ConsultantsChattanoogaTennessee37411
Kaitlyn Harden
[email protected]
(423) 265-3561
David Huffman (PRINCIPAL_INVESTIGATOR)
Texas Diabetes and EndocrinologyAustinTexas78749
Jennifer Perez
[email protected]
(512) 334-3505
Thomas Blevins (PRINCIPAL_INVESTIGATOR)
Tekton ResearchMcKinneyTexas75072
Idolina Garcia
[email protected]
(214) 831-7137
Pablo Mora (PRINCIPAL_INVESTIGATOR)
Tekton ResearchSan AntonioTexas78258
Sharon Jones
[email protected]
(210) 996-2600
Jara McDonald (PRINCIPAL_INVESTIGATOR)
Riverside Family Medicine Residency ProgramNewport NewsVirginia23601
Elizabeth Eckhart
[email protected]
(757) 534-5374
Beth Klug (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Barbara, CA

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Type 2 diabetes
By specialty
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By research site
Sansum Diabetes Research Institute· Santa Barbara, CATouro University California· Vallejo, CAUniversity of Colorado Denver· Denver, COMetabolic Research Institute· West Palm Beach, FLAtlanta Diabetes Associates· Atlanta, GAEndocrine Research Solutions, Inc.· Rosewell, GA

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