Type 1 DiabetesNCT07864168
Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes
A study testing Next Generation Extended Wear Sensors in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 18 sites in United States.
Trial summary
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Next Generation Extended Wear Sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 18 sitesUnited States
- Study dates
- 5 Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 2-80 years at time of screening.
- Has a clinical diagnosis of diabetes as stipulated according to the following age group:
- Age 2-10 years: Has a clinical diagnosis of T1D or T2D as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
- Age 11-80 years: Has a clinical diagnosis of T1D or T2D for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able to read the language offered in the study materials.
- Is willing to provide informed consent/assent for participation.
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- If participating in BGA FST, 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.
- Subject or parent(s)/guardian(s)/caregiver(s) is/are willing to complete the requirements for diary data entry, as applicable.
- If participating in glycemic challenges, has met the following conditions:
- Been using insulin for at least 3 months
- A relatively stable insulin-to-carbohydrate ratio(s) and insulin sensitivity factor(s) for at least one month per investigator assessment Subjects who do not meet the above conditions can be included in the study, however, will participate in the FST under observation only (no glycemic challenges).
Who cannot join
- Unable to consent due to a mental or intellectual disability.
- 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 1 or more episodes of DKA in the last 6 months prior to screening visit.
- T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
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- 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).
- Currently pregnant or planning to become pregnant during the time period of study participation
- A negative pregnancy test will be required for all females of child-bearing potential at time of screening
- For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable
- Has diagnosis of adrenal insufficiency.
- Is using hydroxyurea at time of screening or plans to use it during the study.
- Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study. (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 planned that requires general anesthesia during the course of the study.
- T2D: Is using insulin secretagogue.
- Is, at the discretion of the investigator, abusing drugs or alcohol
- Age 7-80 years: has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that prior blood draw from routine care may be used as long as the prior blood draw was done within 3 months prior to 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 more than 1 year 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. However, subject may participate at the discretion of the investigator and with clearance from the cardiologist.
- 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 sponsor employee or their immediate family member (excluding adult children and/or adult siblings).
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Research Admin, studyadmin@atlantadiabetes.com
Bruce Bode
- Recruiting
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Christie Beatson, 303-724-6761, Christie.beatson@cuanschutz.edu
Satish Garg
- Recruiting
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Lindsey Towers, Lindsey.Towers@cuanschutz.edu
Gregory Forlenza
- Recruiting
Texas Diabetes and Endocrinology
Austin, Texas, 78749
Emmanuel Lopez, 512-334-3505 ext. 3, elopez@texasdiabetes.com
Lindsay Harrison
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
Emma Emory, ee9m@uvahealth.org
Mark DeBoer
- Recruiting
ProSciento
Chula Vista, California, 91911
Gloria Keopuhiwa, gloria.keopuhiwa@prosciento.com
Elaine Watkins
- Not yet recruiting
University of Florida
Gainesville, Florida, 32610
Jennifer Hosford, 352-294-5759, jennifer.hosford@peds.ufl.edu
Michael Haller
- Recruiting
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Isabella Wenstrom, isabella.wenstrom@rmclinicalresearch.com
David Liljenquist
- Not yet recruiting
Yale University School of Medicine
New Haven, Connecticut, 06511
Marcia DeSousa, marcia.desousa@yale.edu
Laura Nally
- Not yet recruiting
Stanford University
Palo Alto, California, 94304
Bailey Suh, 925-389-8516, bysuh@stanford.edu
Rayhan Lal
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
Taylor Smith, 425-271-1720, tsmith@rainier-research.com
Sheryl Marks
- Recruiting
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78240
JoAnn Hernandez, 210-614-8612 ext. 1075, joann.hernandez@dgdclinic.com
Mark Kipnes
- Not yet recruiting
Rady Children's Hospital - San Diego
San Diego, California, 92123
Carla Logan, 858-966-8400, Clogan1@rchsd.org
Anna Cymbaluk
- Not yet recruiting
University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
San Francisco, California, 94158
Avani Narayan, 415-514-6234, avani.narayan@ucsf.edu
Laya Ekhlaspour
- Recruiting
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Alexis Marquardt, amarquardt@sansum.org
Andrew Rhinehart
- Not yet recruiting
Seattle Children's
Seattle, Washington, 98105
Barbara Maslaney, 206-884-8540, barbara.maslaney@seattlechildrens.org
Catherine Pihoker
- Not yet recruiting
University of South Florida (USF) Diabetes and Endocrinology Center
Tampa, Florida, 33612
Elizabeth Doble, 813-974-5529, edoble@usf.edu
Dorothy Shulman
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Sonal Sharma, 925-930-7267, ssharma@flourishresearch.com
Mark Christiansen
About this study
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
Read the detailed description
The study is a multi-center, prospective single-arm design without controls for adult and pediatric subjects with T1D or T2D. The study is anticipated to last approximately 24 months from first investigational center initiation to study completion (last subject, last visit completed). The subject's participation from study enrollment to study exit is approximately up to 46 days (including replacement sensor wear and repeat office procedures if needed).
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Next Generation Extended Wear Sensors
- 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.
Next Generation Extended Wear SensorsDevice
Disposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity
| Study group | Role | What they receive |
|---|---|---|
| Next Generation Extended Wear Sensors | Experimental | All subjects will wear the sensor. Each subject and subject's parent/guardian/caregiver (if applicable) may insert and tape (if applicable) the study glucose sensors once trained or have them inserted and taped (if applicable) by the trained investigational center staff. Receives: Device: Next Generation Extended Wear Sensors |
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
- Adverse events (AE) to include:
- Serious Adverse Events (SAE)
- Device Related AEs
- Procedure Related AEs
- Serious Adverse Device Effects (SADE)
- Unanticipated Adverse Device Effects (UADE)
- Severe hypoglycemia
- Diabetic Ketoacidosis (DKA)
- Hyperosmolar Hyperglycemic State (HHS)
Measured: Approximately up to 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start5 Oct 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864168
- Sponsor's protocol ID
- CIP358
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07864168
- Acronym / sponsor ID
- CIP358
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
Detailed description
The study is a multi-center, prospective single-arm design without controls for adult and pediatric subjects with T1D or T2D. The study is anticipated to last approximately 24 months from first investigational center initiation to study completion (last subject, last visit completed). The subject's participation from study enrollment to study exit is approximately up to 46 days (including replacement sensor wear and repeat office procedures if needed).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Next Generation Extended Wear Sensors | Experimental | Device: Next Generation Extended Wear SensorsAll subjects will wear the sensor. Each subject and subject's parent/guardian/caregiver (if applicable) may insert and tape (if applicable) the study glucose sensors once trained or have them inserted and taped (if applicable) by the trained investigational center staff. |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age 2-80 years at time of screening.
- Has a clinical diagnosis of diabetes as stipulated according to the following age group:
- Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able to read the language offered in the study materials.
- Is willing to provide informed consent/assent for participation.
- If participating in BGA FST, has adequate venous access as assessed by investigator or appropriate staff.
Key exclusion criteria (26 listed)
- Unable to consent due to a mental or intellectual disability.
- 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 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 |
|---|---|---|
| Next Generation Extended Wear SensorsDisposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity | Device | Next Generation Extended Wear Sensors |
Primary outcome
Primary Safety Endpoints
Time frame: Approximately up to 46 days
Descriptive summary will be used to characterize: * Skin assessment of subject's glucose sensor insertion sites * Adverse events (AE) to include: * Serious Adverse Events (SAE) * Device Related AEs * Procedure Related AEs * Serious Adverse Device Effects (SADE) * Unanticipated Adverse Device Effects (UADE) * Severe hypoglycemia * Diabetic Ketoacidosis (DKA) * Hyperosmolar Hyperglycemic State (HHS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Extended Wear Sensors in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 18 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 13 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin Mottackel (818-576-4886, robin.e.mottackel@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoints (time frame: Approximately up to 46 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 20 Oct 2026.