Indianapolis, INNCT07579702Now EnrollingIRB Ready

Type 2 Diabetes Mellitus Clinical Trial in Indianapolis, IN

Access cutting-edge type 2 diabetes mellitus treatment through this clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Insulet Corporation

Quick Self-Assessment

See if you qualify for this Indianapolis location

Preparing your pre-screening questions…

Expert Care in Indianapolis

Access type 2 diabetes mellitus specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related type 2 diabetes mellitus treatment provided free

Apply for This Indianapolis Location

Check if you qualify for this type 2 diabetes mellitus clinical trial in Indianapolis, IN

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Type 2 Diabetes Mellitus Study in Indianapolis

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Sponsor: Insulet Corporation

Who Can Participate

Inclusion Criteria

Age at time of consent 14-75 years (inclusive)
Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
HbA1c ≥ 7.5%
Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
Currently using a continuous glucose monitor
Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
Participant agrees to provide their own insulin for the duration of the study
Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
Willing to wear the system continuously throughout the study
Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged \< 18 years per local regulatory requirements
Able to read and understand English and operate the study device in English
If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria

Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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 judgment of the investigator
History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
Use of hydroxyurea
Plans to receive blood transfusion over the course of the study
Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this 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 of any of the aforementioned

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT07579702) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 2 Diabetes Mellitus Treatment Options in Indianapolis, IN

If you're searching for type 2 diabetes mellitus treatment options in Indianapolis, IN, this clinical trial (NCT07579702) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 2 diabetes mellitus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 2 diabetes mellitus clinical trials near you to find additional studies recruiting in your area.

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