Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.

Key facts

Study ID

NCT05714059

Run by

Medtronic MiniMed, Inc.

People needed

250

Starts

2023-02-28

Expected to finish

2023-12-29

Last updated by the study team

2025-02-17

Who can join

Age: 7 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 7 - 80 years at time of screening.
• Has a clinical diagnosis of type 1 diabetes:
• 14 - 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• 7 - 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
• Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
• Subject and/or legally authorized representative is 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 8 units.
• Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
• Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
• Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience).
• 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:
• Humalog (insulin lispro injection)
• NovoLog (insulin aspart injection)
• Admelog (insulin lispro injection)

You may not qualify if…

• Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
• Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
• Coma
• Seizures
• Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
• Has had DKA in the last 6 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).
• Is female of child-bearing potential and result of pregnancy test is positive at screening.
• Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
• Is female and plans to become pregnant during the course of the study.
• Is being treated for hyperthyroidism at time of screening.
• 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.
• Has used a MiniMed 780G pump prior to screening.
• Is currently abusing illicit drugs.
• Is currently abusing marijuana.
• Is currently abusing prescription drugs.
• Is currently abusing alcohol.
• Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
• 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.

Where it is running

• Medical Investigations — Little Rock, Arkansas, United States
• Stanford University — Palo Alto, California, United States
• University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes — San Francisco, California, United States
• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• University of South Florida (USF) Diabetes Center — Tampa, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Endocrine Research Solutions — Roswell, Georgia, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Park Nicollet International Diabetes Center — Saint Louis Park, Minnesota, United States
• Childrens Hospital and Clinics of Minnesota — Saint Paul, Minnesota, United States
• New York University (NYU) Langone Hospital Long Island — Mineola, New York, United States
• Northwell Health for Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• University Hospitals Rainbow Babies & Childrens Hospital — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• AM Diabetes and Endocrinology Center — Bartlett, Tennessee, United States
• Texas Diabetes and Endocrinology — Round Rock, Texas, United States
• Rainier Clinical Research Center — Renton, Washington, United States
• Seattle Childrens Hospital — Seattle, Washington, United States
• Multicare Institute for Research and Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.