Clinical trial for Type 2 Diabetes Mellitus
Official title Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
ClinicalTrials.gov ID: NCT07521475
What this study is testing
- What it's testing
- The study will see if the Omnipod M System is safe and works well for people with type 2 diabetes who use insulin. The main check is after 15 weeks, with a follow‑up at 26 weeks.
- Who it's for
- Adults who have type 2 diabetes and use either basal/bolus or basal‑only insulin.
- What's involved
- Participants will be randomly assigned to use the Omnipod M System or continue their usual insulin method. They will have regular clinic visits and blood tests to monitor safety and effectiveness.
- Time commitment
- The trial lasts 26 weeks, with visits at the start, 15 weeks, and 26 weeks; after that, the control group may switch to the pump for another 26 weeks.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age at time of consent 18-75 years (inclusive)
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening
- On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months...
- Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c)...
- Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime...
You likely can't join if
- Use of an automated insulin delivery pump 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.
- Current or known history of coronary artery disease that is not stable with medical management in the opinion of the investigator, including unstable...
- Any planned surgery during the study which could be considered major in the opinion of the Investigator
- History of more than 1 episode of severe hypoglycemia in the past 6 months.
- History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an...
See the full eligibility criteria
Who can join
- Age at time of consent 18-75 years (inclusive)
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening
- On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months excluded) to initiating baseline CGM data collection.
- Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin
- Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime insulin dose per day, or a non-automated insulin pump
- Inhaled insulin may be used in addition to or instead of mealtime injections pre-study and as part of the Control group
- For basal only users, screening A1C ≥7.5% and \<14.0%. For basal bolus users (i.e., all others), screening A1C ≥6.0% and \<14.0%.
- A1C measurement within 28 days prior to enrollment is acceptable
- Willing to use only the following types of U-100 insulin while using the study pump: Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic/biosimilar equivalents
- Willing to use only study-provided Libre 2 Plus or 3 Plus sensor during the study and not use another sensor
- Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- No anticipated need to newly initiate noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose lowering effect during the...
- If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose-lowering effect, prescribed dose has been stable for 6...
- Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
- Willing to wear the system, including Pods, continuously throughout the 26-week trial phase
- Willing and able to sign the Informed Consent Form (ICF)
- Able to read and understand English
- If of childbearing potential, willing and able to have pregnancy testing
What rules you out
- Use of an automated insulin delivery pump 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.
- Current or known history of coronary artery disease that is not stable with medical management in the opinion of the investigator, including unstable angina, despite medical management, or a history of myocardial...
- Any planned surgery during the study which could be considered major in the opinion of the Investigator
- History of more than 1 episode 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 consciousness, and requires another...
- History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula
- Unable to tolerate adhesive tape or has any unresolved skin condition that could impact 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
- Plans to receive blood transfusion over the course of the 26-week trial phase.
- Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives...
- Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to baseline CGM collection or plans to take oral or injectable...
- Participation in another clinical study using an investigational drug or device within prior 30 days or intends to participate in any other treatment study during the 26-week trial phase
- 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 a member of Investigator's study team, or immediate family member of any of the aforementioned
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Newport Beach, California, United States
- Santa Barbara, California, United States
- Vallejo, California, United States
- Denver, Colorado, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Rosewell, Georgia, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Bloomington, Indiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Syracuse, New York, United States
- Asheville, North Carolina, United States
- Wilmington, North Carolina, United States
- Portland, Oregon, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Newport Beach, California, United States; Santa Barbara, California, United States; Vallejo, California, United States; Denver, Colorado, United States; West Palm Beach, Florida, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.