Study Stopped
The device is no longer under development.
SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
1 other identifier
interventional
N/A
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2025
Shorter than P25 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 6, 2024
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 3, 2025
May 1, 2025
7 months
December 2, 2024
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Subjects with diabetes wearing DS5
EXPERIMENTALSubjects wearing DS5 over 7-14 days and participating in FSTs
Interventions
CGM and frequent sample testing
Eligibility Criteria
You may qualify if:
- Age 11-80 years at time of screening.
- 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.
- Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
- Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials.
- Subject and/or legally authorized representative is willing to provide informed consent for participation.
- Has adequate venous access as assessed by investigator or appropriate staff.
- Is willing to perform fingerstick blood glucose measurements as needed.
- Is willing to wear the study devices continuously throughout the study.
You may not qualify if:
- Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
- Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
- Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
- Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone.
- Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.
- Has a history of a seizure disorder.
- Has a central nervous system or cardiac disorder resulting in syncope.
- Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- 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).
- Has diagnosis of adrenal insufficiency.
- Is using hydroxyurea at time of screening or plans to use it during the study.
- 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.)
- 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.
- Has elective surgery or hospitalization planned during the course of the study.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
ProSciento
Chula Vista, California, 91911, United States
John Muir Health
Concord, California, 94520, United States
Headlands Research California, LLC
Escondido, California, 92025, United States
Sansum Diabetes Research Institute
Goleta, California, 93111, United States
Rady Children's Hospital
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94158, United States
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, 94401, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32610, United States
Atlanta Diabetes
Atlanta, Georgia, 30318, United States
Endocrine Research Solutions
Roswell, Georgia, 30076, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, 50265, United States
Barry J Reiner, MD, LLC
Baltimore, Maryland, 21229, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Northwell Health
New Hyde Park, New York, 11042v, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
ClinRĂ© 001-007
Bartlett, Tennessee, 38133, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78749, United States
Tekton Research
McKinney, Texas, 75069, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681, United States
Diabetes & Glandular Disease Clinic
San Antonio, Texas, 78229, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2024
First Posted
December 6, 2024
Study Start
May 1, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share