Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
74 participants
INTERVENTIONAL
2020-10-31
2021-06-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections
NCT04145804
Medtronic 670G Insulin Pump and the Impact on Glycemic Control, Quality of Life, and Compliance
NCT04329871
Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.
NCT04073576
The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs
NCT04414280
Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
NCT04051632
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subjects with Type 1 diabetes wearing HCL pump system
Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes.
MiniMed™ 670G system
Hybrid closed loop insulin pump with associated CGM and blood glucose meter
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MiniMed™ 670G system
Hybrid closed loop insulin pump with associated CGM and blood glucose meter
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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. 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.
14 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Diabetes
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yiming Mu, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Yan Bi, MD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Yongde Peng, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Yanbing Li, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIP329
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.