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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Type 1 diabetes wearing HCL pump system | Experimental | Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed™ 670G system | Device | Hybrid closed loop insulin pump with associated CGM and blood glucose meter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
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.
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:
Subject must be able to carbohydrate count or willing to learn how to carbohydrate count for the study.
Exclusion Criteria:
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:
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.)
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China | ||
| The First Affiliated Hospital, Sun Yat-sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37578804 | Derived | 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. |
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There were 74 participants screened in the study. Of the 74 participants, 8 participants failed screening, and 1 participant was withdrawn prior to run-in. Therefore, 65 participants started run-in period. A total of 3 participants were withdrawn during the run-in period. Therefore, a total of 62 participants were included in the Intention to Treat Population and started the study period.
Recruitment started on 31Oct2020 and ended on 30Apr2021. Recruitment was conducted at four hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Type 1 Diabetes Wearing HCL Pump System | Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Period |
|
| ||||||||||||||||||
| Overall Study Period |
|
Intention to Treat Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Type 1 Diabetes Wearing HCL Pump System | Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intention to Treat Population. | Posted | Mean | Standard Deviation | percentage of total readings | Baseline to end of 1-month study |
|
2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Type 1 Diabetes Wearing HCL Pump System During Run in Period | Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during Run in period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site haemorrhage | General disorders | MedDRA24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Statistician | Medtronic MiniMed | +18185764034 | dz.dai@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2020 | May 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | May 25, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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. |
| 1-month study |
| 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 | 1-month study |
| 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. | 1-month study |
| 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. | 1-month study |
| 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. | Baseline to end of 1-month study |
| Change of Weight From Baseline to EOS | Change of weight from baseline to EOS will be summarized. | Baseline to end of 1-month study |
| 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. | 1-month study |
| 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 | 1-month study |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | Intention to Treat Population | Posted | Mean | Standard Deviation | percentage of total readings | 1-month study |
|
|
|
| Secondary | 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. | Intention to Treat Population. | Posted | Mean | Standard Deviation | percentage of total readings | 1-month study |
|
|
|
| Secondary | 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 | Intention to Treat Population. | Posted | Mean | Standard Deviation | mmol/L | 1-month study |
|
|
|
| Secondary | 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. | Intention to Treatment Population | Posted | Mean | Standard Deviation | mg/dL | 1-month study |
|
|
|
| Secondary | 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. | Intention to Treat Population. | Posted | Mean | Standard Deviation | Percentage | 1-month study |
|
|
|
| Secondary | 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. | Intention to Treat Population. | Posted | Mean | Standard Deviation | Units/Day | Baseline to end of 1-month study |
|
|
|
| Secondary | Change of Weight From Baseline to EOS | Change of weight from baseline to EOS will be summarized. | Intention to Treat Population with available data. | Posted | Mean | Standard Deviation | Kg | Baseline to end of 1-month study |
|
|
|
| Secondary | 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. | Intention to Treat Population. | Posted | Mean | Standard Deviation | percentage of time | 1-month study |
|
|
|
| Secondary | 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 | Intention to Treat Population at each subgroup. | Posted | Mean | Standard Deviation | percentage of total readings | 1-month study |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 6 |
| 65 |
| EG001 | Subjects With Type 1 Diabetes Wearing HCL Pump System During Study Period | Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period. | 0 | 62 | 0 | 62 | 9 | 62 |
| Upper respiratory tract infection | Infections and infestations | MedDRA24.0 | Systematic Assessment |
|
| Diabetic ketosis | Metabolism and nutrition disorders | MedDRA24.0 | Systematic Assessment | For study period, one is device related, the other is non-device related. |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA24.0 | Systematic Assessment | For run in period: One is device Device related severe hyperglycemia, the other is not device related. For study period: Device related severe hyperglycemia. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA24.0 | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title |
|---|
| Measurements |
|---|
|
| SG < 60 mg/dL (3.3 mmol/L) |
|
| SG < 70 mg/dL (3.9 mmol/L) |
|
| 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) |
|
| SG > 180 mg/dL (10 mmol/L) |
|
| SG > 250 mg/dL (13.9 mmol/L) |
|
| SG > 350 mg/dL (19.4 mmol/L) |
|