Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM

Type 1 Diabetes Clinical Trial

Official title:

Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714059
• Other study ID #: CIP337
• Status: Completed
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Insulin Pump with Continuous Glucose Monitoring
MiniMed™ 780G insulin pump in combination with the DS5 CGM

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	AM Diabetes and Endocrinology Center	Bartlett	Tennessee
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University Hospitals Rainbow Babies & Childrens Hospital	Cleveland	Ohio
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho
United States	Medical Investigations	Little Rock	Arkansas
United States	New York University (NYU) Langone Hospital Long Island	Mineola	New York
United States	Yale School of Medicine	New Haven	Connecticut
United States	Northwell Health for Cohen Children's Medical Center of New York	New Hyde Park	New York
United States	Stanford University	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Texas Diabetes and Endocrinology	Round Rock	Texas
United States	Park Nicollet International Diabetes Center	Saint Louis Park	Minnesota
United States	Childrens Hospital and Clinics of Minnesota	Saint Paul	Minnesota
United States	University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes	San Francisco	California
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Seattle Childrens Hospital	Seattle	Washington
United States	Multicare Institute for Research and Innovation	Tacoma	Washington
United States	University of South Florida (USF) Diabetes Center	Tampa	Florida
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint for Age 18-80 - Change in HbA1c	Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.	3 months
Primary	Primary Safety Endpoint for Age 7-17 - Change in HbA1c	Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.	3 months
Primary	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.	3 months
Primary	Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)	Age 7-17: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.	3 months
Secondary	Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)	Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL) . Non-inferiority test.	3 months
Secondary	Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL)	Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL). Non-inferiority test.	3 months
Secondary	Secondary Effectiveness Endpoint 2 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).Superiority test.	3 months
Secondary	Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)	Age 7-17: The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.	3 months