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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05224258




Registration number
NCT05224258
Ethics application status
Date submitted
24/01/2022
Date registered
4/02/2022
Date last updated
27/06/2024

Titles & IDs
Public title
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
Scientific title
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)
Secondary ID [1] 0 0
CIP336
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - MiniMed 780G System

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.


Treatment: Devices: MiniMed 780G System
780G System used with Insulin Fiasp® (Insulin Aspart Injection)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint for Age 18-80 - Change in HbA1c
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Primary Safety Endpoint for Age 7-17 - Change in HbA1c
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Timepoint [3] 0 0
3 months
Primary outcome [4] 0 0
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Timepoint [4] 0 0
3 months
Secondary outcome [1] 0 0
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Timepoint [4] 0 0
3 months

Eligibility
Key inclusion 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.
Minimum age
7 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2024
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Childrens Hospital - New Lambton
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Diabetes
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05224258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Liljenquist, MD
Address 0 0
Rocky Mountain Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries