Clinical trial NCT05815342: OP5-005 Using Omnipod 5 in Adults With Type 2
Official title: Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: T2D
Omnipod
Automated Insulin Delivery
Lead sponsor: Insulet Corporation
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2023-04-18
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Detailed description: This outpatient study consists of 2 phases.

Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information.

Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

Eligibility criteria: Inclusion Criteria:

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 (long-acting insulin and rapid acting analog) or pre-mix users with A1C \<12.0% OR basal users on long or intermediate acting insulin only with A1C \> 7.0% and \< 12.0%
4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
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 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. Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
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 or Spanish
12. Willing and able to sign the Informed Consent Form (ICF)
13. If female of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

1. Use of an AID pump in automated mode within 3 months 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. 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
4. Any planned surgery during the study which could be considered major in the opinion of the investigator
5. History of more than 1 severe hypoglycemic event in the 6 months prior to screening
6. 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
7. 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
8. Plans to receive blood transfusion over the course of the study
9. Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study
10. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
11. 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)
12. Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period
13. 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
14. 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Comparing the change in HbA1c during the 13 weeks study phase
Secondary outcomes:
measure: Mean Glucose
timeFrame: Measuring mean glucose during the 13 weeks study phase
measure: Percentage of time in range 70-180 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percent of Time in Range 70-140 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percent of Time ≥ 300 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percent of Time > 250 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percent of Time >180 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percent of Time < 70 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percent of Time < 54 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Change from baseline in T2-DDAS total score
timeFrame: Baseline compared to end of week 13 visit
measure: % Meeting MCID for T2-DDAS
timeFrame: Baseline compared to end week 13 visit
measure: Change from baseline in Pittsburgh Sleep Quality Index total score
timeFrame: Baseline compared to end of week 13 visit
measure: % Meeting MCID for Pittsburgh Sleep Quality Index
timeFrame: Baseline compared to end of week 13 visit
measure: Change from baseline in HCS total score
timeFrame: Baseline compared to end week 13 visit
measure: % Meeting MCID for HCS
timeFrame: Baseline compared to end week 13 visit
measure: Percentage of time <70 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Percentage of time <54 mg/dL
timeFrame: Measured during 13 weeks study phase
measure: Coefficient of variation
timeFrame: Measured during 13 weeks study phase and compared to standard therapy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Canton
country: United States
facility: East Coast Institute for Research
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research
state: Georgia
city: Boston
country: United States
facility: Joslin Diabetes
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Minneapolis
country: United States
facility: Health Partners
state: Minnesota
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Asheville
country: United States
facility: MAHEC
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Wilmington
country: United States
facility: AccellaCare
state: North Carolina
city: Columbus
country: United States
facility: Ohio State
state: Ohio
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
Study officials:
affiliation: Emory School of Medicine
name: Francisco J Pasquel, MD
role: STUDY_CHAIR
References: