Clinical trial NCT06719531: SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
Official title: SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Primary Safety Endpoints
timeFrame: The subject's participation from study enrollment to study exit is approximately 7 to 44 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chula Vista
country: United States
facility: ProSciento
state: California
city: Concord
country: United States
facility: John Muir Health
state: California
city: Escondido
country: United States
facility: Headlands Research California, LLC
state: California
city: Goleta
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Medical Center: Diabetes Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Center
state: Iowa
city: Baltimore
country: United States
facility: Barry J Reiner, MD, LLC
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Bartlett
country: United States
facility: ClinRé 001-007
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: McKinney
country: United States
facility: Tekton Research
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
References: