Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes

November 12, 2026 updated by: Medtronic MiniMed, Inc.

This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
      • Escondido, California, United States, 92025-6428
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Rayhan Lal
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
        • Principal Investigator:
          • Anna Cymbaluk
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
        • Contact:
        • Principal Investigator:
          • Laya Ekhlaspour
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Sansum Diabetes Research Institute
        • Contact:
        • Principal Investigator:
          • Andrew Rhinehart
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Diablo Clinical Research, Inc.
        • Principal Investigator:
          • Mark Christiansen
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Not yet recruiting
        • Yale University School of Medicine
        • Contact:
        • Principal Investigator:
          • Laura Nally
    • Florida
      • Gainesville, Florida, United States, 32610
        • Not yet recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Michael Haller
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • University of South Florida (USF) Diabetes and Endocrinology Center
        • Contact:
        • Principal Investigator:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, United States, 30318
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Texas
      • Austin, Texas, United States, 78749
        • Recruiting
        • Texas Diabetes and Endocrinology
        • Contact:
        • Principal Investigator:
          • Lindsay Harrison
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Diabetes and Glandular Disease Clinic
        • Principal Investigator:
          • Mark Kipnes
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • Mark DeBoer
    • Washington
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Sheryl Marks
        • Contact:
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 2-80 years at time of screening.

  2. Has a clinical diagnosis of diabetes as stipulated according to the following age group:

    1. 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.
    2. 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.

  3. Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able to read the language offered in the study materials.

  4. Is willing to provide informed consent/assent for participation.

  5. If participating in BGA FST, has adequate venous access as assessed by investigator or appropriate staff.

  6. Is willing to perform fingerstick blood glucose measurements as needed.

  7. Is willing to wear the study devices continuously throughout the study.

  8. Subject or parent(s)/guardian(s)/caregiver(s) is/are willing to complete the requirements for diary data entry, as applicable.

  9. If participating in glycemic challenges, has met the following conditions:

    1. Been using insulin for at least 3 months
    2. 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).

Exclusion Criteria:

  1. Unable to consent due to a mental or intellectual disability.

  2. Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.

  3. Has had a hypoglycemic seizure within the past 6 months prior to screening visit.

  4. Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.

  5. Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.

  6. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.

  7. Has a history of a seizure disorder.

  8. Has a central nervous system or cardiac disorder resulting in syncope.

  9. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.

  10. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

  11. Currently pregnant or planning to become pregnant during the time period of study participation

    1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening
    2. 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

  12. Has diagnosis of adrenal insufficiency.

  13. Is using hydroxyurea at time of screening or plans to use it during the study.

  14. 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.)

  15. 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.

  16. Has elective surgery planned that requires general anesthesia during the course of the study.

  17. T2D: Is using insulin secretagogue.

  18. Is, at the discretion of the investigator, abusing drugs or alcohol

  19. 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).

  20. 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.

  21. 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.

  22. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

  23. Is a member of the research staff involved with the study.

  24. Is a sponsor employee or their immediate family member (excluding adult children and/or adult siblings).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Next Generation Extended Wear Sensors

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.
Device: Next Generation Extended Wear Sensors

Disposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Approximately up to 46 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic MiniMed, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP358

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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