SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
NCT ID: NCT06719531
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-05-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Subjects with diabetes wearing DS5
Subjects wearing DS5 over 7-14 days and participating in FSTs
Continuous Glucose Monitoring
CGM and frequent sample testing
Interventions
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Continuous Glucose Monitoring
CGM and frequent sample testing
Eligibility Criteria
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Inclusion Criteria
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
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).
11 Years
80 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
ProSciento
Chula Vista, California, United States
John Muir Health
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Sansum Diabetes Research Institute
Goleta, California, United States
Rady Children's Hospital
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Atlanta Diabetes
Atlanta, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, United States
Barry J Reiner, MD, LLC
Baltimore, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Northwell Health
New Hyde Park, New York, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
ClinRé 001-007
Bartlett, Tennessee, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Tekton Research
McKinney, Texas, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, United States
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
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Other Identifiers
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CIP345
Identifier Type: -
Identifier Source: org_study_id
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