Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM
1 other identifier
interventional
250
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedStudy Start
First participant enrolled
February 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedResults Posted
Study results publicly available
February 17, 2025
CompletedFebruary 17, 2025
January 1, 2025
10 months
January 26, 2023
December 20, 2024
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Safety Endpoint - Change in HbA1c
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
3 months
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Last 6-7 weeks of 3 month study period
Secondary Outcomes (2)
Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Last 6-7 weeks of 3 month study period
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)
Last 6-7 weeks of 3 month study period
Study Arms (1)
MiniMed™ 780G system with DS5
EXPERIMENTALSubjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.
Interventions
MiniMed™ 780G insulin pump in combination with the DS5 CGM
Eligibility Criteria
You may qualify if:
- Age 7 - 80 years at time of screening.
- Has a clinical diagnosis of type 1 diabetes:
- 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.
- 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:
- +3 more criteria
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.
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Medical Investigations
Little Rock, Arkansas, 72211, United States
Stanford University
Palo Alto, California, 94304, United States
University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes
San Francisco, California, 94158, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Yale School of Medicine
New Haven, Connecticut, 06511, United States
University of South Florida (USF) Diabetes Center
Tampa, Florida, 33612, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Endocrine Research Solutions
Roswell, Georgia, 30076, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Park Nicollet International Diabetes Center
Saint Louis Park, Minnesota, 55416, United States
Childrens Hospital and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
New York University (NYU) Langone Hospital Long Island
Mineola, New York, 11501, United States
Northwell Health for Cohen Children's Medical Center of New York
New Hyde Park, New York, 11042, United States
University Hospitals Rainbow Babies & Childrens Hospital
Cleveland, Ohio, 44106, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Seattle Childrens Hospital
Seattle, Washington, 98105, United States
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- DZ Dai, Sr Statistician
- Organization
- Medtronic Diabetes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2023
First Posted
February 6, 2023
Study Start
February 28, 2023
Primary Completion
December 29, 2023
Study Completion
December 29, 2023
Last Updated
February 17, 2025
Results First Posted
February 17, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share