COMPLETED

Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

Conditions

Diabetes Mellitus, Type 1, Type 2 T1D Omnipod Omnipod 5 T2D

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.

Official Title

Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

Quick Facts

Study Start:2025-03-26

Study Completion:2025-11-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06865989

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age at time of consent 2-70 years (inclusive) 2. Diabetes diagnosis, based on Investigators clinical judgement, and meets the following: 3. Living with a parent or guardian if \< 18 years old 4. Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening 5. Must have used the target of 110mg/dl for at least 30% of the time for 2-13 year olds and for at least 50% of the time for 14-70 year olds for the 2 weeks preceding the screening visit 6. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents 7. Participant agrees to provide their own insulin for the duration of the study 8. Stable doses over the preceding 4 weeks of non-insulin glucose lowering or weight loss medications that have a meaningful effect on glycemia, as determined by the investigator 9. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol 10. Willing to wear the system continuously throughout the study 11. Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged \< 18 years per state requirements 12. Able to read and understand English 13. If of childbearing potential, willing and able to have pregnancy testing	1. Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk 2. Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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 3. Any planned surgery during the study which could be considered major in the judgment of the investigator 4. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions. 5. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure 6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 7. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c 8. Use of hydroxyurea 9. Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study 10. For type 1 participants only. Use of non-insulin glucose-lowering medication other than metformin and GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose during study participation 11. Pregnant or lactating, or 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) 12. In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device. Additionally, may not intend to participate in any other clinical study during this study period. 13. Planned international travel during the study 14. 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 15. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Inclusion Criteria

Exclusion Criteria

1. Age at time of consent 2-70 years (inclusive)
2. Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
3. Living with a parent or guardian if \< 18 years old
4. Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening
5. Must have used the target of 110mg/dl for at least 30% of the time for 2-13 year olds and for at least 50% of the time for 14-70 year olds for the 2 weeks preceding the screening visit
6. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
7. Participant agrees to provide their own insulin for the duration of the study
8. Stable doses over the preceding 4 weeks of non-insulin glucose lowering or weight loss medications that have a meaningful effect on glycemia, as determined by the investigator
9. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
10. Willing to wear the system continuously throughout the study
11. Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged \< 18 years per state requirements
12. Able to read and understand English
13. If of childbearing potential, willing and able to have pregnancy testing

1. Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
2. Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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
3. Any planned surgery during the study which could be considered major in the judgment of the investigator
4. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
5. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
7. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
8. Use of hydroxyurea
9. Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
10. For type 1 participants only. Use of non-insulin glucose-lowering medication other than metformin and GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose during study participation
11. Pregnant or lactating, or 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)
12. In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device. Additionally, may not intend to participate in any other clinical study during this study period.
13. Planned international travel during the study
14. 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
15. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Contacts and Locations

Principal Investigator

Gregory Forlenza, MD

STUDY_CHAIR

Barbara Davis Center

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90022

United States

Sansum Diabetes Research Institute

Santa Barbara, California, 93105

United States

University of Colorado Denver

Aurora, Colorado, 80045

United States

Yale University School of Medicine

New Haven, Connecticut, 06511

United States

Northwestern University

Chicago, Illinois, 60611

United States

Joslin Diabetes Center

Boston, Massachusetts, 02215

United States

Henry Ford

Detroit, Michigan, 48202

United States

International Diabetes Center

Minneapolis, Minnesota, 55416

United States

University Hospitals Cleveland

Cleveland, Ohio, 44106

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Insulet Corporation

Gregory Forlenza, MD, STUDY_CHAIR, Barbara Davis Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2025-11-10

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2025-11-10

Terms related to this study

Keywords Provided by Researchers

T1D
Omnipod
Omnipod 5
T2D

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1, Type 2