Clinical trial NCT04663295: MiniMed™ 670G System China Study for Type I Diabetic
Official title: Safety, Effectiveness and Usability Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Adult and Adolescent Subjects in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes
Type 1
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 74
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
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 obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China. The results from the study will be submitted to the NMPA for product registration.

Detailed description: This study is a multi-center, single arm study in insulin-requiring subjects with type 1 diabetes who are 14 years of age and older. The run-in period will be approximately up to 35 days long, followed by a study period that will be approximately up to 33 days in duration.

The study is anticipated to last no longer than 13 months from investigational center initiation to completion of all data entry and monitoring procedures. The study will target approximately 5 months to complete subject enrollment. Subjects can expect to participate for approximately 2-3 months including the run-in and study periods.

A total of up to 75 subjects (aged 14-75) will be enrolled at a minimum 2 investigational centers and up to 6 investigational centers (hospitals) in China to have at least 50 subjects who complete the study.

The MiniMed™ HCL system that was employed in this study was the MiniMed™ 670G Bluetooth version (MMT-1883). The MiniMed™ 670G system with Bluetooth™ technology is the MiniMed™ 770G system.

Eligibility criteria: Inclusion Criteria:

1. Subject is age 14- 75 years at time of Screening.
2. Subject has 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.

   Study-specific inclusion criteria
3. Subject is willing to perform ≥ 4 finger stick BG measurements daily.
4. Subject is willing to perform required sensor calibrations.
5. Subject is willing to wear the system continuously throughout the study.
6. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
7. Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by the investigational center lab or their contracted Local Lab) at time of Screening visit.
8. Subject 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. Prior labs in the last 6 months are sufficient.
9. Subject has been on pump therapy for greater than 6 months prior to screening (with or without CGM experience).
10. Subject is willing to upload data from the study pump and meter at home.
11. If subject has celiac disease, it has been adequately treated as determined by the investigator.
12. Subject has been taking and is willing to take one of the following insulins throughout the course of the study:

    * Humalog™\* (insulin lispro injection)
    * NovoLog™\* (insulin aspart)
13. Subject must be able to carbohydrate count or willing to learn how to carbohydrate count for the study.

Exclusion Criteria:

1. Subject 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. Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes.
3. Subject has had DKA in the 6 months prior to Screening.
4. Subject is unable to tolerate tape adhesive in the area of sensor placement.
5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
6. Subject is a female of child-bearing potential who has a positive pregnancy test at Screening or plans to become pregnant during the course of the study.
7. Subject is a female who is sexually active and able to conceive should be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
8. Subject 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, ventricular rhythm disturbances or thromboembolic disease.
9. Subject is being treated for hyperthyroidism at time of Screening.
10. Subject has a diagnosis of adrenal insufficiency.
11. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
12. Subject 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. (Please note participation in an observational study is acceptable.)
13. Subject is currently abusing illicit drugs.
14. Subject is currently abusing alcohol.
15. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Screening.
16. Subject 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.
17. Subject has elective surgery planned that requires general anesthesia during the course of the study.
18. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening
19. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
20. Subject diagnosed with current eating disorder such as anorexia or bulimia
21. Subject has been diagnosed with chronic kidney disease that results in chronic anemia.
22. Subject has a hematocrit (Hct) that is below the normal reference range of lab used. Prior labs in the last 6 months are sufficient.
23. Subject is on dialysis.
24. Subject has an estimated glomerular filtration rate (eGFR) of \< 30.
25. Subject has a pediatric BMI category of underweight (less than the 5th percentile) as defined by Centers for Disease Control (CDC) (https://www.cdc.gov/healthyweight/assessing/bmi/childrens_bmi/about_childrens_bmi.html)
26. Subject is a member the research staff involved with the study.

Primary outcomes:
measure: Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
timeFrame: Baseline to end of 1-month study
Secondary outcomes:
measure: Time in Hypoglycemic Range
timeFrame: 1-month study
measure: Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)
timeFrame: 1-month study
measure: Standard Deviation (SD) of SG in mmol/L
timeFrame: 1-month study
measure: Standard Deviation (SD) of SG in mg/dL
timeFrame: 1-month study
measure: Coefficient of Variation (CV) of SG
timeFrame: 1-month study
measure: Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)
timeFrame: Baseline to end of 1-month study
measure: Change of Weight From Baseline to EOS
timeFrame: Baseline to end of 1-month study
measure: Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop)
timeFrame: 1-month study
measure: Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
timeFrame: 1-month study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Chinese PLA General Hospital
name: Yiming Mu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yan Bi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Yongde Peng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yanbing Li, MD
role: PRINCIPAL_INVESTIGATOR
References: