Clinical trial for Type 1 Diabetes
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
What this study is testing
- What it's testing
- The study collects data from the new sensors to learn how they work in people with diabetes.
- Who it's for
- People aged 2 to 80 who have type 1 or type 2 diabetes.
- What's involved
- Participants will wear the MiniMed sensors and have their data recorded by the system.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 80
You may be able to join if
- Age 2-80 years at time of screening.
- 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...
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- Age 2-80 years at time of screening.
- 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.
- 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.
- 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 people who do not meet the above conditions can be included in the study...
What rules you out
- 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.
- 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.
- 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...
- 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Chula Vista, California, United States
- Santa Barbara, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Idaho Falls, Idaho, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Charlottesville, Virginia, United States
- Renton, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chula Vista, California, United States; Santa Barbara, California, United States; Walnut Creek, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Idaho Falls, Idaho, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.