Clinical trial NCT05409131: Omnipod 5 System Compared to Pump Therapy
Official title: Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: T1D
Omnipod
Automated Insulin Delivery
Lead sponsor: Insulet Corporation
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

Detailed description: This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth.

Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system.

Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system.

Eligibility criteria: Inclusion Criteria:

1. Age at time of consent 18-70 years of age
2. Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
3. On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating.
4. A1C 7.0-11.0% by point-of-care taken at screening visit
5. Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment
6. Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study
7. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
8. Willing to wear the system continuously throughout the study
9. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk
2. History of severe hypoglycemia in the past 6 months
3. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
4. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
5. Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.
6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
7. Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation.
8. Pregnant or lactating, or is a woman 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)
9. Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other study during this study period
10. 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
11. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Primary outcomes:
measure: Percent of Time in Range 70-180 mg/dL
timeFrame: Comparing intervention group with control group during the 13-week study phase
Secondary outcomes:
measure: Percent of Time <54 mg/dL (Non-inferiority)
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
measure: Percent of Time >180 mg/dL
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
measure: Mean Glucose
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
measure: Change in HbA1c
timeFrame: Baseline compared to end of study visit (Day -30 to Day 90)
measure: Percent of Time <70 mg/dL
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
measure: Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score
timeFrame: Baseline compared to end of study visit (Day -14 to Day 90)
measure: Change in Hypoglycemic Confidence Scale (HCS) Total Score
timeFrame: Baseline compared to end of study visit (Day -14 to Day 90)
measure: Change in Diabetes Quality of Life (DQOL)-Brief Total Score
timeFrame: Baseline compared to end of study visit (Day -14 to Day 90)
measure: Proportion of Participants With T1-DDS MCID After 13 Weeks
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
measure: Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
measure: Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks
timeFrame: Comparing intervention group with control group at the end of the 13-week study phase
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Syracuse
country: United States
facility: State University of New York, Upstate Medical University
state: New York
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Corbeil-Essonnes
country: France
facility: Hopital Sud-Francilien
city: Lyon
country: France
facility: Hospices Civils de Lyon - Centre du diabete Diab-eCare
city: Montpellier
country: France
facility: CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition
city: Paris
country: France
facility: Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Ruth Weinstock, MD
role: STUDY_CHAIR
affiliation: Lapeyronie Montpellier University Hospital
name: Eric Renard, Pr
role: STUDY_CHAIR
References: