Type 1 Diabetes study: Omnipod M System vs Omnipod S
Official title Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D
ClinicalTrials.gov ID: NCT07593625
What this study is testing
- What it's testing
- The study wants to find out if the Omnipod algorithm is safe and practical for people with type 1 diabetes.
- Who it's for
- People who have type 1 diabetes.
- What's involved
- Participants will use the Omnipod insulin pump with the new algorithm and attend a short hotel stay and outpatient clinic visits for monitoring and tests.
- Time commitment
- The study includes a brief hotel stay and several outpatient visits over a few weeks.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Age at time of consent 2-70 years (inclusive)
- Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment
- Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or without automation
- Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents
- Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and...
You likely can't join if
- 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, including unstable angina, 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 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another...
- History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness
- Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
See the full eligibility criteria
Who can join
- Age at time of consent 2-70 years (inclusive)
- Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment
- Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or without automation
- Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents
- Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening
- Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
- 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 participants per local regulatory requirements
- Able to read and understand English
- If of childbearing potential, willing and able to have pregnancy testing
What rules you out
- 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, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery...
- Any planned surgery during the study which could be considered major in the opinion of the Investigator
- History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to...
- History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula
- 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 corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during...
- Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and/or GLP1, in the 4 weeks prior to screening.
- 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...
- In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device that in the opinion of the investigator may have therapeutic impact on their diabetes management.
- 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
- Christchurch, New Zealand
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, 2 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Christchurch, New Zealand. 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.