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

Retiré
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L'essai clinique NCT06719531 est une étude interventionnel pour Diabète sucré de type 1, Diabète sucré de type 2. Son statut actuel est : retiré. L'étude a débuté le 1 mai 2025 et vise à recruter N/A participants. Dirigée par Medtronic Diabetes, l'étude devrait être terminée d'ici le 1 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 3 juin 2025.
Résumé succinct
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.
Titre officiel

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

Pathologies
Diabète sucré de type 1Diabète sucré de type 2
Autres identifiants de l'étude
  • CIP345
Numéro NCT
NCT06719531
Date de début (réel)
2025-05
Dernière mise à jour publiée
2025-06-03
Date de fin (estimée)
2025-12
Type d'étude
Interventionnel
PHASE
N/A
Statut
Retiré
Objectif principal
Autre
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalSubjects with diabetes wearing DS5
Subjects wearing DS5 over 7-14 days and participating in FSTs
Surveillance continue de la glycémie
CGM and frequent sample testing
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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.
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
11 Years
Sexes éligibles
Tous
  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.

  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).
Medtronic Diabetes logoMedtronic Diabetes
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28 Centres de l'étude dans 1 pays

Alabama

University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

California

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

Colorado

Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States
Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States

Florida

University of Florida, Gainesville, Florida, 32610, United States

Georgia

Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Endocrine Research Solutions, Roswell, Georgia, 30076, United States

Idaho

Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States

Iowa

Iowa Diabetes and Endocrinology Center, West Des Moines, Iowa, 50265, United States

Maryland

Barry J Reiner, MD, LLC, Baltimore, Maryland, 21229, United States

Massachusetts

Joslin Diabetes Center, Boston, Massachusetts, 02215, United States

New York

Northwell Health, New Hyde Park, New York, 11042v, United States

North Carolina

Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, 27104, United States

Pennsylvania

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States

Tennessee

ClinRé 001-007, Bartlett, Tennessee, 38133, United States

Texas

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

Virginia

University of Virginia Health System, Charlottesville, Virginia, 22903, United States

Washington

Rainier Clinical Research Center, Renton, Washington, 98057, United States