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Diabetes Mellitus, Type 1NCT04663295

MiniMed™ 670G System China Study for Type I Diabetic

A study testing MiniMed™ 670G system in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
MiniMed™ 670G system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
4 sitesChina
Study dates
31 Oct 2020to 22 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Study-specific inclusion criteria
  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.)
  • Subject is currently abusing illicit drugs.
  • Subject is currently abusing alcohol.
  • 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.
  • 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.
  • Subject has elective surgery planned that requires general anesthesia during the course of the study.
  • Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening
  • Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  • Subject diagnosed with current eating disorder such as anorexia or bulimia
  • Subject has been diagnosed with chronic kidney disease that results in chronic anemia.
  • Subject has a hematocrit (Hct) that is below the normal reference range of lab used. Prior labs in the last 6 months are sufficient.
  • Subject is on dialysis.
  • Subject has an estimated glomerular filtration rate (eGFR) of < 30.
  • 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)
  • Subject is a member the research staff involved with the study.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

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

    Nanjing, Jiangsu, 210008

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: Safety, Effectiveness and Usability Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Adult and Adolescent Subjects in Chinese Population

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.

Read the 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.

Being tested
MiniMed™ 670G system
Keywords
Diabetes, Type 1
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiniMed™ 670G systemDevice

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

Study groups in NCT04663295
Study groupRoleWhat they receive
Subjects with Type 1 diabetes wearing HCL pump systemExperimentalSubjects 14-75 years of age who have been diagnosed with Type 1 diabetes.
Receives: Device: MiniMed™ 670G system

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to end of 1-month study

Secondary outcomes (9)

  1. Time in Hypoglycemic Range

    Time in hypoglycemic range (% of SG): SG < 70 mg/dL (3.9 mmol/L), SG < 60 mg/dL (3.3 mmol/L), SG < 54 mg/dL (3.0 mmol/L) will be summarized.

    Measured: 1-month study

  2. 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)

    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)) will be summarized.

    Measured: 1-month study

  3. Standard Deviation (SD) of SG in mmol/L

    In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mmol/L

    Measured: 1-month study

  4. Standard Deviation (SD) of SG in mg/dL

    In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mg/dL.

    Measured: 1-month study

  5. Coefficient of Variation (CV) of SG

    In order to evaluate glucose variation, we calculated coefficient of variation (CV) of SG. The glucose coefficient of variation (CV) will be summarized in percentage.

    Measured: 1-month study

  6. Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)

    Change of Total Daily Dose (TDD) of insulin from baseline to EOS will be summarized.

    Measured: Baseline to end of 1-month study

  7. Change of Weight From Baseline to EOS

    Change of weight from baseline to EOS will be summarized.

    Measured: Baseline to end of 1-month study

  8. Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop)

    Time spent in Auto Mode (HCL) and time spent in Manual Mode (open loop) will be summarized.

    Measured: 1-month study

  9. Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)

    Time in target range (% of SG): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) in study period Time in hypoglycemic range (% of SG): SG < 70 mg/dL (3.9 mmol/L), 60 mg/dL (3.3 mmol/L) and 54 mg/dL (3.0 mmol/L) in study period 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) in study period

    Measured: 1-month study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start31 Oct 2020
  3. Primary completion22 Jun 2021
  4. Study completion22 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663295
Sponsor's protocol ID
CIP329
Status last verified
Aug 2022
First submitted
28 Oct 2020
Last updated
30 Aug 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 37578804

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed™ 670G system in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Baseline to end of 1-month study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04663295, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.

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