No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 80
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
1,500 (estimated)
Sponsor
Medtronic MiniMed, Inc. · Industry
Who this trial is looking for
This trial is looking for patients aged 2 to 80 with type 1 or type 2 diabetes. Participants will wear a sensor and provide blood samples during the study.
Are You a Good Fit for This Trial?
Rules you outAdrenal insufficiencySeizure disorder
You may be able to join if
I am between the ages of 2 and 80.
I have been diagnosed with diabetes.
I can read the study materials.
I am willing to give my consent to participate.
I can perform blood glucose measurements as needed.
I am willing to wear the study devices continuously.
I can complete diary data entries as required.
You may not be able to join if
I cannot consent due to a mental or intellectual disability.
I have had a severe low blood sugar episode in the last 6 months.
I have had a seizure related to low blood sugar in the last 6 months.
I have had unconsciousness due to low blood sugar in the last 6 months.
I have had diabetic ketoacidosis in the last 6 months.
I am currently pregnant or planning to become pregnant.
I have a history of a seizure disorder.
I am using hydroxyurea.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.