Simplified Onboarding in Adults With Type 2 Diabetes (SIMPLEUSE)

Insulet

Status

Not yet enrolling

Conditions

Type 2 Diabetes Mellitus

Treatments

Device: Active Comparator: Omnipod M System with lower starting dose

Device: Active Comparator: Omnipod M System with higher starting dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT07070830

SIMPLEUSE

Details and patient eligibility

About

This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM).

There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.

The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age at time of consent 18-75 years
Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix)
Basal-bolus (non-AID pump & MDI), pre-mix, or basal only users suitable for conversion to AID pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, they must have A1c <12%. For basal only users must have A1c >7% and <12%.
Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
Participant agrees to provide their own insulin for the duration of the study
Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
Stable doses of weight loss medications over the preceding 4 weeks, and plans to maintain throughout the study, that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, as determined by Investigator
Willing to wear the system continuously throughout the study
Participant agrees to provide their own compatible smartphone for use with the Dexcom G6 CGM
Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
Able to read and understand English
Willing and able to sign the Informed Consent Form (ICF)
If female of childbearing potential, willing and able to have pregnancy testing

Exclusion criteria

Use of an AID pump in automated mode up to 90 days prior to screening
Any medical condition which in the opinion of the Investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
Arrhythmias or other cardiac conditions confirmed by ECG (within past 30 days) 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 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 opinion of the Investigator
History of more than 1 severe hypoglycemic event in 6 months prior to screening
History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis
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
Has taken systemic steroids (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 the study
Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
Planned international travel during the study
Participation in another clinical study using an investigational drug or device other than the Omnipod in the 30 days prior to screening or intends to participate during the 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 (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned