Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT06604871

Run by

Medtronic MiniMed, Inc.

People needed

56

Starts

2024-10-29

Expected to finish

2025-09-26

Last updated by the study team

2025-10-08

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Stanford University — Palo Alto, California, United States
• UCSF The Madison Clinic for Pediatric Diabetes — San Francisco, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Nemours Childrens Specialty Care — Jacksonville, Florida, United States
• USF Diabetes and Endocrinology Center — Tampa, Florida, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Texas Childrens Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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