OP5-005 Using Omnipod 5 in Adults With Type 2

Type2 Diabetes Clinical Trial

— SECURE-T2D  

Official title:

Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815342
• Other study ID #: G230013
• Status: Completed
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Insulet Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Device:
• Omnipod 5 Automated Glucose Control System
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Locations

Country	Name	City	State
United States	MAHEC	Asheville	North Carolina
United States	Emory	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Joslin Diabetes	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	East Coast Institute for Research	Canton	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University Diabetes and Endocrine Consultants	Chattanooga	Tennessee
United States	Ohio State	Columbus	Ohio
United States	Henry Ford	Detroit	Michigan
United States	Diabetes and Thyroid Center	Fort Worth	Texas
United States	Physicians East	Greenville	North Carolina
United States	East Coast Institute for Research	Jacksonville	Florida
United States	University of Southern California	Los Angeles	California
United States	Health Partners	Minneapolis	Minnesota
United States	Endocrine Research	Roswell	Georgia
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Metabolic Research Institute	West Palm Beach	Florida
United States	AccellaCare	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Insulet Corporation	Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	The change in HbA1c at 13 weeks from baseline	Comparing the change in HbA1c during the 13 weeks study phase
Secondary	Mean Glucose	Glucose metric from study provided continuous glucose monitor (CGM)	Measuring mean glucose during the 13 weeks study phase
Secondary	Percentage of time in range 70-180 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Percent of Time in Range 70-140 mg/dL	Glucose metric from study CGM	Measured during 13 weeks study phase
Secondary	Percent of Time = 300 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Percent of Time = 250 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Percent of Time >180 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Percent of Time < 70 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Percent of Time < 54 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Change from baseline in T2-DDAS total score	A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.	Baseline compared to end of week 13 visit
Secondary	% Meeting MCID for T2-DDAS	A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.	Baseline compared to end week 13 visit
Secondary	Change from baseline in PSQI total score	Change from baseline in PSQI total score	Baseline compared to end of week 13 visit
Secondary	% Meeting MCID for PSQI	Change from baseline in PSQI total score	Baseline compared to end of week 13 visit
Secondary	Change from baseline in HCS total score	Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.	Baseline compared to end week 13 visit
Secondary	% Meeting MCID for HCS	Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.	Baseline compared to end week 13 visit
Secondary	Percentage of time <70 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Percentage of time <54 mg/dL	Glucose metric from CGM	Measured during 13 weeks study phase
Secondary	Coefficient of variation	Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)	Measured during 13 weeks study phase and compared to standard therapy