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

Medtronic MiniMed, Inc.

Status: Enrolling

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Device: Next Generation Extended Wear Sensors

Study type: Interventional

Funder types: Industry

Identifiers

NCT07864168

CIP358

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,500 estimated patients

Sex: All

Ages: 2 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

Next Generation Extended Wear Sensors

Experimental group

Description:

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.

Treatment:

Device: Next Generation Extended Wear Sensors