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

NCT05224258 | Completed Results DMC FDA Device

• 1 other identifier: CIP336
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 18

Brief 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.

Conditions

Type 1 Diabetes

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 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])

  The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]). 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 [3.0 mmol/L])

  Last 6-7 weeks of 3 month study period

• Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])

  Last 6-7 weeks of 3 month study period

Study Arms (1)

MiniMed 780G System Utilizing Insulin Fiasp

EXPERIMENTAL

Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.

Device: MiniMed 780G System

Interventions

MiniMed 780G System DEVICE

780G System used with Insulin Fiasp® (Insulin Aspart Injection)

MiniMed 780G System Utilizing Insulin Fiasp

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 one of the languages offered in the pump.
• 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 and maximum total daily dose of 250 units or less.
• 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 sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
• 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.

You may not qualify if:

• Has hypersensitivity to insulin aspart or one of the excipients in Fiasp.
• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (18)

Medical Investigations, Inc.

Little Rock, Arkansas, 72211, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95821, United States

Location

Rady's Children's Hospital

San Diego, California, 92123, United States

Location

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Barry J Reiner MD, LLC

Baltimore, Maryland, 21229, United States

Location

The Docs, LLC

Las Vegas, Nevada, 89113, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

John Hunter Childrens Hospital

New Lambton, New South Wales, 2305, Australia

Location

Alberta Children's Hospital Research Institute

Calgary, Alberta, T3B 6A8, Canada

Location

LMC Clinical Research

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Thomas Troub, Sr Clinical Research Program Manager
• Organization: Medtronic Diabetes

thomas.troub@medtronic.com

8052089091

Study Officials

• David Liljenquist, MD

  Rocky Mountain Clinical Research

  PRINCIPAL INVESTIGATOR

• Mark Warren, MD

  Physicians East

  PRINCIPAL INVESTIGATOR

• John Reed, MD

  Endocrine Research Solutions

  PRINCIPAL INVESTIGATOR

• Frances Broyles, MD

  Rainier Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Dorothy Shulman, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Bruce Bode, MD

  Atlanta Diabetes Associates

  PRINCIPAL INVESTIGATOR

• Halis Akturk, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Paul Norwood, MD

  Valley Research

  PRINCIPAL INVESTIGATOR

• Carla Demeterco-Berggren, MD

  Rady's Children's Hospital

  PRINCIPAL INVESTIGATOR

• Alexander Abitbol, MD

  LMC Clinical Research

  PRINCIPAL INVESTIGATOR

• Daniele Pacaud, MD

  Alberta Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• James Thrasher, MD

  Medical Investigations, Inc.

  PRINCIPAL INVESTIGATOR

• Bhuvana Sunil, MD

  MultiCare Institute for Research & Innovation

  PRINCIPAL INVESTIGATOR

• Mark Kipnes, MD

  Diabetes and Glandular Disease Clinic, P.A.

  PRINCIPAL INVESTIGATOR

• Asheesh Dewan, MD

  The Docs LLC

  PRINCIPAL INVESTIGATOR

• Barry Reiner, MD

  Barry J Reiner MD LLC

  PRINCIPAL INVESTIGATOR

• Gnanagurudasan Prakasam, MD

  Sutter Institute for Medical Research

  PRINCIPAL INVESTIGATOR

• Bruce King, MD

  John Hunter Childrens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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 24, 2022
• First Posted: February 4, 2022
• Study Start: March 17, 2022
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: June 22, 2025
• Results First Posted: June 22, 2025

Record last verified: 2025-06

Locations

CA (2); US (15); AU (1)