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Simplified Onboarding in Adults With Type 2 Diabetes (SIMPLEUSE) 56 Randomized

Completed
Clinical Trial NCT07070830 (SIMPLEUSE) was an interventional study for Type 2 Diabetes Mellitus that is now completed. The study started on July 18, 2025, with plans to enroll 56 participants. Led by Insulet Corporation, the expected completion date was January 6, 2026. The latest data from ClinicalTrials.gov was last updated on January 30, 2026.
Brief Summary
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). The main objectives of the study are to evaluate the safety and tolerability of different star...Show More
Official Title

Feasibility of Simplified Onboarding in Adults With Type 2 Diabetes Using Automated Insulin Delivery

Conditions
Type 2 Diabetes Mellitus
Other Study IDs
  • SIMPLEUSE
NCT ID Number
NCT07070830
Start Date (Actual)
2025-07-18
Last Update Posted
2026-01-30
Completion Date (Estimated)
2026-01-06
Enrollment (Estimated)
56
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
T2D
Type 2 Diabetes
Omnipod
Omnipod 5
Automated Insulin Delivery
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorOmnipod M System with lower starting dose
Active Comparator: Omnipod M System with lower starting dose
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Active ComparatorOmnipod M System with higher starting dose
Active Comparator: Omnipod M System with higher starting dose
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percent of time >180 mg/dL
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time <70 mg/dL
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percent of time in range (TIR) 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time above range (TAR) >250 mg/dL
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time below range (TBR) <54 mg/dL
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin (TDI)
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin/kg
Glucose metric from study continuous glucose monitoring system
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Perception questionnaire
Includes questions about participant's private attitudes, feelings, and behavior related to the investigational device as well as managing diabetes.
Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Weight
Measures change in weight
Comparing baseline to end of continuation phase in the randomized trial.
HbA1c
Measures changes in HbA1c
Comparing baseline to end of continuation phase in the randomized trial.
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age at time of consent 18-75 years
  2. 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)
  3. 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 <14%. For basal only users must have A1c >7% and <14%.
  4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
  5. Participant agrees to provide their own insulin for the duration of the study
  6. Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
  7. 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
  8. Willing to wear the system continuously throughout the study
  9. Participant agrees to provide their own compatible smartphone for use with the Dexcom G6 CGM
  10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
  11. Able to read and understand English
  12. Willing and able to sign the Informed Consent Form (ICF)
  13. If female of childbearing potential, willing and able to have pregnancy testing

  1. Use of an AID pump in automated mode up to 90 days prior to screening
  2. 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)
  3. 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
  4. 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
  5. Any planned surgery during the study which could be considered major in the opinion of the Investigator
  6. History of more than 1 severe hypoglycemic event in 6 months prior to screening
  7. 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
  8. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
  9. Use of hydroxyurea
  10. 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
  11. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
  12. 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)
  13. Planned international travel during the study
  14. 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
  15. 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
  16. 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
Insulet Corporation logoInsulet Corporation
No contact data.
6 Study Locations in 1 Countries

Colorado

University of Colorado, Aurora, Colorado, 80045, United States

Georgia

Emory University, Atlanta, Georgia, 30303, United States

Massachusetts

Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
MassResearch LLC., Waltham, Massachusetts, 02453, United States

North Carolina

AccellaCare, Wilmington, North Carolina, 28401, United States

Texas

Disease & Glandular Disease Clinic, San Antonio, Texas, 78229, United States