Clinical trial NCT05224258: Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
Official title: Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 240
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Primary Safety Endpoint for Age 18-80 - Change in HbA1c
timeFrame: 3 months
measure: Primary Safety Endpoint for Age 7-17 - Change in HbA1c
timeFrame: 3 months
measure: Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
timeFrame: 3 months
measure: Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
timeFrame: 3 months
Secondary outcomes:
measure: Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
timeFrame: 3 months
measure: Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
timeFrame: 3 months
measure: Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
timeFrame: 3 months
measure: Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
timeFrame: 3 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Medical Investigations, Inc.
state: Arkansas
city: Fresno
country: United States
facility: Valley Research
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Diego
country: United States
facility: Rady's Children's Hospital
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Baltimore
country: United States
facility: Barry J Reiner MD, LLC
state: Maryland
city: Las Vegas
country: United States
facility: The Docs, LLC
state: Nevada
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic, P.A.
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: New Lambton
country: Australia
facility: John Hunter Childrens Hospital
state: New South Wales
city: Calgary
country: Canada
facility: Alberta Children's Hospital Research Institute
state: Alberta
city: Toronto
country: Canada
facility: LMC Clinical Research
state: Ontario
Study officials:
affiliation: Rocky Mountain Clinical Research
name: David Liljenquist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physicians East
name: Mark Warren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine Research Solutions
name: John Reed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainier Clinical Research Center
name: Frances Broyles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Dorothy Shulman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Halis Akturk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valley Research
name: Paul Norwood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rady's Children's Hospital
name: Carla Demeterco-Berggren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LMC Clinical Research
name: Alexander Abitbol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital Research Institute
name: Daniele Pacaud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Investigations, Inc.
name: James Thrasher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MultiCare Institute for Research & Innovation
name: Bhuvana Sunil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes and Glandular Disease Clinic, P.A.
name: Mark Kipnes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Docs LLC
name: Asheesh Dewan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barry J Reiner MD LLC
name: Barry Reiner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Institute for Medical Research
name: Gnanagurudasan Prakasam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John Hunter Childrens Hospital
name: Bruce King, MD
role: PRINCIPAL_INVESTIGATOR
References: