SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes

The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.

Study Overview

• Status: Withdrawn
• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitoring

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Chula Vista, California, United States, 91911
      • ProSciento
    • Concord, California, United States, 94520
      • John Muir Health
    • Escondido, California, United States, 92025
      • Headlands Research California, LLC
    • Goleta, California, United States, 93111
      • Sansum Diabetes Research Institute
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
    • San Francisco, California, United States, 94158
      • University of California San Francisco
    • San Mateo, California, United States, 94401
      • Mills-Peninsula Medical Center: Diabetes Research Institute
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Diabetes
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Center
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Barry J Reiner, MD, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • New York
    • New Hyde Park, New York, United States, 11042v
      • Northwell Health
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Atrium Health Wake Forest Baptist
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • ClinRé 001-007
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes and Endocrinology
    • McKinney, Texas, United States, 75069
      • Tekton Research
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health System
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 11-80 years at time of screening.
2. Has a clinical diagnosis of type 1 or type 2 diabetes for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
4. Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials.
5. Subject and/or legally authorized representative is willing to provide informed consent for participation.
6. Has adequate venous access as assessed by investigator or appropriate staff.
7. Is willing to perform fingerstick blood glucose measurements as needed.
8. Is willing to wear the study devices continuously throughout the study.

Exclusion Criteria:

1. Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
2. Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
3. Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
4. Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone.
5. Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.
6. Has a history of a seizure disorder.
7. Has a central nervous system or cardiac disorder resulting in syncope.
8. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
9. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
10. Is pregnant or lactating, 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).
11. Has diagnosis of adrenal insufficiency.
12. Is using hydroxyurea at time of screening or plans to use it during the study.
13. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. (Please note participation in an observational study is acceptable.)
14. Has a planned procedure involving the use of a Magnetic Resonance Imaging (MRI), diathermy devices, or other devices that generate strong magnetic fields (e.g., x-ray, CT scan, or other types of radiation) during the study wear period.
15. Has elective surgery or hospitalization planned during the course of the study.
16. Has a clinical diagnosis of type 1 and is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 receptor agonist, metformin, and/or SGLT2 inhibitor at time of screening.
17. Is currently abusing illicit drug(s).
18. Is currently abusing marijuana.
19. Is currently abusing prescription medication(s).
20. Is currently abusing alcohol.
21. Has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
22. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
23. Has had any of the following cardiovascular events 1 year or more prior to screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. Subject may be enrolled if clearance from a cardiologist is provided prior to or at screening.
24. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
25. Is a member of the research staff involved with the study.
26. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with diabetes wearing DS5; Subjects wearing DS5 over 7-14 days and participating in FSTs	Device: Continuous Glucose Monitoring; CGM and frequent sample testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoints	Descriptive summary will be used to characterize: • Skin assessment of subject's glucose sensor insertion sites	The subject's participation from study enrollment to study exit is approximately 7 to 44 days.

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CIP345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No