RecruitingNot applicable

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how well the Omnipod 6 and Omnipod 5 systems work. It is for people ages 14–75 with type 1 or type 2 diabetes whose blood sugar is above target. Participants will use both systems during the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 14–75 and have had type 1 diabetes for at least 6 months or type 2 diabetes for at least 1 year.
  • Use background and mealtime insulin through daily shots or a pump, and currently use a continuous glucose monitor.
  • Have an HbA1c of at least 7.5%. This blood test shows your average blood sugar over time.
  • Give yourself fewer than 4 extra insulin doses, called boluses, per day on average during two 14-day periods: before screening and during the usual-treatment phase.
  • Supply your own insulin and use only these U-100 insulins: Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev, or their generic versions.
  • If taking noninsulin diabetes or weight-loss medicines, have a steady dose for 6 weeks before screening. Agree not to change it unless needed for safety.
  • Be able to use the devices safely and follow study rules, with caregiver help if needed. Agree to wear the system throughout the study and be able to read, understand, and use it in English.
  • Sign the consent form, or have a parent or guardian sign. Those under 18 must also agree as local rules require. Agree to pregnancy tests if you could become pregnant.

Who can't join

  • Have a health problem that makes the study unsafe, unstable heart artery disease, or heart-related chest pain that limits moderate exercise despite treatment. A heart attack, procedure to open heart arteries, or heart bypass surgery in the past 12 months also rules you out, as does planned major surgery.
  • Have had very low blood sugar needing another person's help in the past 6 months. Also excluded: DKA or HHS—serious diabetes emergencies—in that time, unless caused by another illness or a failure to deliver insulin.
  • Cannot tolerate adhesive tape, or have an ongoing skin problem where the sensor or pump would go.
  • Have had a blood disorder in the past 3 months that could affect HbA1c testing, take hydroxyurea, or plan to receive a blood transfusion during the study.
  • Have taken steroid pills or shots that affect the whole body in the past 4 weeks, had a local steroid shot in the past week, or plan to take steroid pills or shots during the study.
  • In the past 4 weeks, have taken a noninsulin diabetes medicine other than metformin or a GLP-1 medicine for type 1 diabetes, or a sulfonylurea medicine for type 2 diabetes.
  • Are pregnant or breastfeeding, or could become pregnant and are not using an accepted form of birth control. Not having sex is also accepted.
  • Used an experimental drug or device in another study within 30 days, plan to join another study, or cannot follow this study's rules. Insulet employees, study investigators, study team members, and their immediate family members cannot join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (11)

CA

CO

CT

GA

  • Emory University · Atlanta, GA 30308Sabeena Usman · Study contactGeorgia Davis · Principal investigatorMore trials in Atlanta

IL

IN

MA

MI

MN

TX