Loading clinical trials...

Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT05714059•Medtronic Diabetes

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.

Detailed Description

This study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5 as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.

Eligibility

Age

7 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 7 - 80 years at time of screening.
•2. Has a clinical diagnosis of type 1 diabetes:
•1. 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.
•2. 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.
•3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
•4. Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
•5. Subject and/or legally authorized representative is willing to provide informed consent for participation.
•6. Is willing to perform fingerstick blood glucose measurements as needed.
•7. Is willing to wear the system continuously throughout the study.
•8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
+8 more criteria

Exclusion Criteria

•1. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
•1. Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
•2. Coma
•3. Seizures
•2. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
•3. Has had DKA in the last 6 months prior to screening visit.
•4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
•5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
•6. Is female of child-bearing potential and result of pregnancy test is positive at screening.
•7. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
+35 more criteria

Locations (23)

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

Key Dates

Start Date

February 28, 2023

Primary Completion Date

December 29, 2023

Completion Date

December 29, 2023

Last Updated

February 17, 2025

Enrollment

250

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Insulin Pump with Continuous Glucose Monitoring

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Dysautonomia in Children With Type 1 Diabetes

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Lipoprotein Kinetics in T1D

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery