Safety Evaluation of MiniMed™ 780G System with DS5 CGM in Children
a study on Diabetes Diabetes Type 1
Summary
- Eligibility
- for people ages 2-6 (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion around
Description
Summary
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.
Official Title
Safety Evaluation of the MiniMed™ 780G System Used in Combination with the DS5 CGM in Children 2-6 Years of Age
Details
This study is a multi-center, single arm study in insulin-requiring pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5. The run-in period and study period, together, will be approximately 130 days long.
Keywords
Type 1 Diabetes, Type 1 Diabetes Mellitus, Insulin, Insulin Pump with Continuous Glucose Monitoring
Eligibility
You can join if…
Open to people ages 2-6
- Age 2-6 years at time of screening.
- Has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials.
- Subject or parent(s)/guardian(s) is/are willing to provide informed consent for participation.
- Is willing to perform fingerstick blood glucose measurements as needed.
- Is willing to wear the system continuously throughout the study.
- Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average.
Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
Note: All HbA1c blood specimens will be collected via fingerstick and sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
- Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
- Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study per manufacturers labeling:
- Humalog (insulin lispro injection)
- Authorized generic insulin lispro
- NovoLog (insulin aspart injection)
- Authorized generic insulin aspart
- Admelog (insulin lispro injection) - for subjects aged 3 years and older only
- Has 1 month or more of CGM experience at time of screening.
- If subject has been diagnosed with hyperthyroidism or hypothyroidism, he/she must have a TSH within 3 months prior to screening or at time of screening.
You CAN'T join if...
- Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening.
- Has been hospitalized or has visited the emergency room (ER) in the 3 months prior to screening resulting with a primary diagnosis of uncontrolled diabetes.
- Has had DKA in the last 3 months prior to screening visit.
- 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).
- Has diagnosis of adrenal insufficiency.
- Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
- Is using hydroxyurea at time of screening or plans to use it during the study.
- Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
- Is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
- Parent(s)/guardian(s) has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
- Has elective surgery planned that requires general anesthesia during the course of the study.
- Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
- Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
- Is diagnosed with current eating disorder such as anorexia or bulimia.
- History of chronic renal disease or currently on hemodialysis
- Has hemophilia or any other bleeding disorder.
- Has celiac disease that is not adequately treated as determined by the investigator.
- Has a cardiovascular condition which the investigator determines must exclude the subject.
- Has hyperthyroidism or hypothyroidism that is not adequately treated as determined by the investigator.
- Is an immediate family member of a Medtronic Diabetes employee.
Locations
- UCSF The Madison Clinic for Pediatric Diabetes
San Francisco California 94158 United States - Stanford University
Palo Alto California 94304 United States
Details
- Status
- not yet accepting patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Medtronic Diabetes
- ID
- NCT06604871
- Study Type
- Interventional
- Participants
- Expecting 60 study participants
- Last Updated