MiniMed™ 670G System China Study for Type I Diabetic

NCT04663295 | Completed Results FDA Device

• 1 other identifier: CIP329
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes; Type 1

Outcome Measures

Primary Outcomes (1)

• Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)

  The overall mean change in % of time in target range from run-in period to study period will be estimated and compared by a simple superiority paired test and a significance level of 0.025 (one-sided).

  Baseline to end of 1-month study

Secondary Outcomes (9)

• Time in Hypoglycemic Range

  1-month study

• 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)

  1-month study

• Standard Deviation (SD) of SG in mmol/L

  1-month study

• Standard Deviation (SD) of SG in mg/dL

  1-month study

• Coefficient of Variation (CV) of SG

  1-month study

Study Arms (1)

Subjects with Type 1 diabetes wearing HCL pump system

EXPERIMENTAL

Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes.

Device: MiniMed™ 670G system

Interventions

MiniMed™ 670G system DEVICE

Hybrid closed loop insulin pump with associated CGM and blood glucose meter

Subjects with Type 1 diabetes wearing HCL pump system

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is age 14- 75 years at time of Screening.
• 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.
• Subject is willing to perform ≥ 4 finger stick BG measurements daily.
• Subject is willing to perform required sensor calibrations.
• Subject is willing to wear the system continuously throughout the study.
• Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
• 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.
• 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.
• Subject has been on pump therapy for greater than 6 months prior to screening (with or without CGM experience).
• Subject is willing to upload data from the study pump and meter at home.
• If subject has celiac disease, it has been adequately treated as determined by the investigator.
• 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)
• Subject must be able to carbohydrate count or willing to learn how to carbohydrate count for the study.

You may not qualify if:

• 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:
• Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
• Coma
• Seizures
• Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes.
• Subject has had DKA in the 6 months prior to Screening.
• Subject is unable to tolerate tape adhesive in the area of sensor placement.
• Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• 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.
• 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.
• 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.
• Subject is being treated for hyperthyroidism at time of Screening.
• Subject has a diagnosis of adrenal insufficiency.
• 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.
• 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.)

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (4)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (1)

• Pei Y, Ke W, Lu J, Lin Y, Zhang Z, Peng Y, Bi Y, Li Y, Hou J, Zhang X, Chen X, Treminio Y, Lee SW, Shin J, Rhinehart AS, Vigersky RA, Mu Y. Safety Event Outcomes and Glycemic Control with a Hybrid Closed-Loop System Used by Chinese Adolescents and Adults with Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2023 Oct;25(10):718-725. doi: 10.1089/dia.2023.0234. Epub 2023 Sep 5.

  PMID: 37578804 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Senior Statistician
• Organization: Medtronic MiniMed

dz.dai@medtronic.com

+18185764034

Study Officials

• Yiming Mu, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Yan Bi, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Yongde Peng, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Yanbing Li, MD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: December 11, 2020
• Study Start: October 31, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: August 30, 2022
• Results First Posted: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)