Status:
COMPLETED
Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06604871
Start Date
October 29 2024
End Date
September 26 2025
Last Update
October 8 2025
Active Locations (8)
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1
Stanford University
Palo Alto, California, United States, 94304
2
UCSF The Madison Clinic for Pediatric Diabetes
San Francisco, California, United States, 94158
3
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
4
Yale School of Medicine
New Haven, Connecticut, United States, 06511