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

• ClinicalTrials.gov Identifier: NCT05224258
• Recruitment Status: Active, not recruiting
• First Posted: February 4, 2022
• Last Update Posted: April 5, 2024
• Sponsor: Medtronic Diabetes
• Information provided by (Responsible Party): Medtronic Diabetes

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Device: MiniMed 780G System	Not Applicable

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 240 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)
• Actual Study Start Date: March 17, 2022
• Estimated Primary Completion Date: July 2024
• Estimated Study Completion Date: July 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: MiniMed 780G System Utilizing Insulin Fiasp; 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; 780G System used with Insulin Fiasp® (Insulin Aspart Injection)

Outcome Measures

Primary Outcome Measures :

1. Primary Safety Endpoint for Age 18-80 - Change in HbA1c [ Time Frame: 3 months ]
   Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
2. Primary Safety Endpoint for Age 7-17 - Change in HbA1c [ Time Frame: 3 months ]
   Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
3. Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) [ Time Frame: 3 months ]
   Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]). Non-inferiority test.
4. Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) [ Time Frame: 3 months ]
   Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]). Non-inferiority test.

Secondary Outcome Measures :

1. Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L]) [ Time Frame: 3 months ]
   Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). Non-inferiority test.
2. Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L]) [ Time Frame: 3 months ]
   Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). Non-inferiority test.
3. Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) [ Time Frame: 3 months ]
   Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).Superiority test.
4. Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) [ Time Frame: 3 months ]
   Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).Superiority test.

Eligibility Criteria

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

Criteria

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. 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.

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 either of the 2 insulin preparations as required during the run-in period:

    1. Humalog (insulin lispro injection)
    2. NovoLog/NovoRapid (insulin aspart injection)
14. Is willing to take Fiasp insulin during the study period (supplied via Sponsor).

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.
8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
9. Is female and plans to become pregnant during the course of the study.
10. Is being treated for hyperthyroidism at time of screening.
11. Has diagnosis of adrenal insufficiency.
12. 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.
13. Is using hydroxyurea at time of screening or plans to use it during the study.
14. 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.
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. Has used a MiniMed 780G pump prior to screening.

Contacts and Locations

Locations

United States, Arkansas

Medical Investigations, Inc.

Little Rock, Arkansas, United States, 72211

United States, California

Valley Research

Fresno, California, United States, 93720

Sutter Institute for Medical Research

Sacramento, California, United States, 95821

Rady's Children's Hospital

San Diego, California, United States, 92123

United States, Colorado

Barbara Davis Center for Diabetes

Aurora, Colorado, United States, 80045

United States, Florida

University of South Florida

Tampa, Florida, United States, 33612

United States, Georgia

Atlanta Diabetes Associates

Atlanta, Georgia, United States, 30318

Endocrine Research Solutions

Roswell, Georgia, United States, 30076

United States, Idaho

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States, 83404

United States, Maryland

Barry J Reiner MD, LLC

Baltimore, Maryland, United States, 21229

United States, Nevada

The Docs, LLC

Las Vegas, Nevada, United States, 89113

United States, North Carolina

Physicians East

Greenville, North Carolina, United States, 27834

United States, Texas

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, United States, 78229

United States, Washington

Rainier Clinical Research Center

Renton, Washington, United States, 98057

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States, 98405

Australia, New South Wales

John Hunter Childrens Hospital

New Lambton, New South Wales, Australia, 2305

Canada, Alberta

Alberta Children's Hospital Research Institute

Calgary, Alberta, Canada, T3B 6A8

Canada, Ontario

LMC Clinical Research

Toronto, Ontario, Canada, M4G 3E8

Sponsors and Collaborators

Medtronic Diabetes

Investigators

• Principal Investigator: 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

More Information

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT05224258
• Other Study ID Numbers: CIP336
• First Posted: February 4, 2022
• Last Update Posted: April 5, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases