RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 46 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests MiniMed next-generation sensors made for longer wear and the software that works with them. It collects sensor data from people ages 2–80 with type 1 or type 2 diabetes.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 2–80 years old and have type 1 or type 2 diabetes. People ages 11–80 must have had diabetes for at least 6 months.
  • You or your parent, guardian, or caregiver must be able to read the language used in the study materials.
  • Be willing to give consent or age-appropriate agreement to join.
  • For the BGA FST part of the study, have veins suitable for blood draws.
  • Be willing to check blood sugar with fingersticks when needed.
  • Be willing to wear the study devices all the time during the study.
  • You or your parent, guardian, or caregiver must be willing to keep a study diary when needed.
  • For blood sugar challenges, have used insulin for at least 3 months and had stable insulin dosing ratios for at least 1 month. Others may join the FST part with observation only, without challenges.

Who can't join

  • Cannot give consent because of a mental or intellectual disability; have a seizure disorder; or have a brain, nerve, or heart condition that causes fainting.
  • In the past 6 months, had severe low blood sugar, a seizure or loss of consciousness from low blood sugar, or DKA (dangerous acid buildup from diabetes). For type 2 diabetes, this also includes HHS (very high blood sugar with severe dehydration).
  • Cannot tolerate sensor tape, have an ongoing skin problem where the sensor goes, have adrenal insufficiency (too little adrenal hormone), or have another condition the study doctor says prevents joining. Ages 7–80 cannot join if their red blood cell percentage is more than 10% below the normal range's lower limit.
  • Are pregnant or plan to become pregnant during the study. Those who could become pregnant need a negative pregnancy test; the doctor will review birth control if sexually active.
  • Use or plan to use hydroxyurea; have type 2 diabetes and take medicine that makes the body release insulin; or misuse drugs or alcohol, as judged by the study doctor.
  • Had a heart attack, chest pain, heart bypass surgery or stent, stroke or mini-stroke, heart failure, or an abnormal rhythm in the heart's lower chambers within the past year. Earlier events need approval from the study doctor and a heart doctor.
  • Have another drug or device trial within 2 weeks before joining or during this study; observation-only studies are allowed. Planned MRI, X-ray, CT, radiation, certain heat treatments, or other strong-field procedures during device wear also exclude you, as does planned nonurgent surgery requiring you to be fully asleep.
  • Are research staff working on this study, a sponsor employee, or an employee's immediate family member. Adult children and adult siblings are not excluded by this family rule.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (18)

CA

CO

CT

FL

GA

ID

TX

VA

WA