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Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® | Clinical Trials | Clareo Health

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Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)

NCT05224258•Medtronic Diabetes

View on ClinicalTrials.gov

Summary

This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.

Detailed Description

This global 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 Fiasp insulin as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long. A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States, Canada, and Australia in order to have 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age group (18 years or older)

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 one of the languages offered in the pump.
•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 and maximum total daily dose of 250 units or less.
+9 more criteria

Exclusion Criteria

•1. Has hypersensitivity to insulin aspart or one of the excipients in Fiasp.
•2. 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
•3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
•4. Has had DKA in the last 6 months prior to screening visit.
•5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
•6. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
•7. Is female of child-bearing potential and result of pregnancy test is positive at screening.
+35 more criteria

Locations (18)

Medical Investigations, Inc.

Little Rock, Arkansas, United States

Valley Research

Fresno, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

Rady's Children's Hospital

San Diego, California, United States

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

University of South Florida

Tampa, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Endocrine Research Solutions

Roswell, Georgia, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Barry J Reiner MD, LLC

Baltimore, Maryland, United States

Key Dates

Start Date

March 17, 2022

Primary Completion Date

June 21, 2024

Completion Date

June 21, 2024

Last Updated

June 22, 2025

Enrollment

240

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

MiniMed 780G System

DEVICE

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RECRUITINGNA

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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: June 22, 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.

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Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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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