Clinical trial NCT05714059: Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
Official title: Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 250
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: 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.

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.

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 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).

Primary outcomes:
measure: Primary Safety Endpoint - Change in HbA1c
timeFrame: 3 months
measure: Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
timeFrame: Last 6-7 weeks of 3 month study period
Secondary outcomes:
measure: Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
timeFrame: Last 6-7 weeks of 3 month study period
measure: Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)
timeFrame: Last 6-7 weeks of 3 month study period
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Medical Investigations
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida (USF) Diabetes Center
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 Diabetes and Osteoporosis Center
state: Idaho
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Saint Louis Park
country: United States
facility: Park Nicollet International Diabetes Center
state: Minnesota
city: Saint Paul
country: United States
facility: Childrens Hospital and Clinics of Minnesota
state: Minnesota
city: Mineola
country: United States
facility: New York University (NYU) Langone Hospital Long Island
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health for Cohen Children's Medical Center of New York
state: New York
city: Cleveland
country: United States
facility: University Hospitals Rainbow Babies & Childrens Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Childrens Hospital
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
Study officials:
References: