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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Insulin Pump with Continuous Glucose Monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Medical Investigations
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • San Francisco, California, United States, 94158
      • University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale School of Medicine
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida (USF) Diabetes Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet International Diabetes Center
    • Saint Paul, Minnesota, United States, 55102
      • Childrens Hospital and Clinics of Minnesota
  • New York
    • Mineola, New York, United States, 11501
      • New York University (NYU) Langone Hospital Long Island
    • New Hyde Park, New York, United States, 11042
      • Northwell Health for Cohen Children's Medical Center of New York
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Rainbow Babies & Childrens Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
  • Texas
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes and Endocrinology
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center
    • Seattle, Washington, United States, 98105
      • Seattle Childrens Hospital
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
10. 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.
11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience).
12. 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.

13. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:

    1. Humalog (insulin lispro injection)
    2. NovoLog (insulin aspart injection)
    3. Admelog (insulin lispro injection)

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.
8. Is female and plans to become pregnant during the course of the study.
9. Is being treated for hyperthyroidism at time of screening.
10. Has diagnosis of adrenal insufficiency.
11. 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.
12. Is using hydroxyurea at time of screening or plans to use it during the study.
13. 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.
14. Has used a MiniMed 780G pump prior to screening.
15. Is currently abusing illicit drugs.
16. Is currently abusing marijuana.
17. Is currently abusing prescription drugs.
18. Is currently abusing alcohol.
19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
20. 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.
21. Has elective surgery planned that requires general anesthesia during the course of the study.
22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
24. Is diagnosed with current eating disorder such as anorexia or bulimia.
25. Has been diagnosed with chronic kidney disease that results in chronic anemia.
26. Has a hematocrit that is below the normal reference range of lab used.
27. Is on dialysis.
28. Has serum creatinine of >2 mg/dL.
29. Has celiac disease that is not adequately treated as determined by the investigator.
30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

31. Has had history of cardiovascular event 1 year or more from the time of screening without

    1. a normal EKG and stress test within 6 months prior to screening or during screening or
    2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.

32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:

    • Age >35 years
    • Type 1 diabetes of >15 years' duration
    • Presence of any additional risk factor for coronary artery disease
    • Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
    • Presence of peripheral vascular disease
    • Presence of autonomic neuropathy
33. Is a member of the research staff involved with the study.
34. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MiniMed™ 780G system with DS5; Subjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.	Device: Insulin Pump with Continuous Glucose Monitoring; MiniMed™ 780G insulin pump in combination with the DS5 CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)	The mean % of time in hypoglycemia (< 54 mg/dL) . Non-inferiority test.	Last 6-7 weeks of 3 month study period
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)	The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.	Last 6-7 weeks of 3 month study period

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin
• Other Study ID Numbers: CIP337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes