Type 1 Diabetes MellitusNCT06719531
SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
A study testing Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 28 sitesUnited States
- Study dates
- May 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- 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.
- Is currently abusing illicit drug(s).
- Is currently abusing marijuana.
- Is currently abusing prescription medication(s).
- Is currently abusing alcohol.
- 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).
- 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.
- 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.
- Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- Is a member of the research staff involved with the study.
- Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Atlanta Diabetes
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78749
Barry J Reiner, MD, LLC
Baltimore, Maryland, 21229
ClinRé 001-007
Bartlett, Tennessee, 38133
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Virginia Health System
Charlottesville, Virginia, 22903
ProSciento
Chula Vista, California, 91911
John Muir Health
Concord, California, 94520
Headlands Research California, LLC
Escondido, California, 92025
University of Florida
Gainesville, Florida, 32610
Sansum Diabetes Research Institute
Goleta, California, 93111
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Tekton Research
McKinney, Texas, 75069
Northwell Health
New Hyde Park, New York, 11042v
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rainier Clinical Research Center
Renton, Washington, 98057
Endocrine Research Solutions
Roswell, Georgia, 30076
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681
Diabetes & Glandular Disease Clinic
San Antonio, Texas, 78229
Rady Children's Hospital
San Diego, California, 92123
University of California San Francisco
San Francisco, California, 94158
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, 94401
Diablo Clinical Research
Walnut Creek, California, 94598
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, 50265
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27104
About this study
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.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
CGM and frequent sample testing
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetes wearing DS5 | Experimental | Subjects wearing DS5 over 7-14 days and participating in FSTs Receives: Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoints
Descriptive summary will be used to characterize:
- Skin assessment of subject's glucose sensor insertion sites
Measured: The subject's participation from study enrollment to study exit is approximately 7 to 44 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: The device is no longer under development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719531
- Sponsor's protocol ID
- CIP345
- Status last verified
- May 2025
- First submitted
- 2 Dec 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06719531
- Acronym / sponsor ID
- CIP345
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The device is no longer under development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with diabetes wearing DS5 | Experimental | Device: Continuous Glucose MonitoringSubjects wearing DS5 over 7-14 days and participating in FSTs |
Who may qualify
- Ages
- 11 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitoringCGM and frequent sample testing | Device | Subjects with diabetes wearing DS5 |
Primary outcome
Primary Safety Endpoints
Time frame: The subject's participation from study enrollment to study exit is approximately 7 to 44 days.
Descriptive summary will be used to characterize: • Skin assessment of subject's glucose sensor insertion sites
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoints (time frame: The subject's participation from study enrollment to study exit is approximately 7 to 44 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.