N/A
Completed N=65
MiniMed™ 670G System China Study for Type I Diabetic
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT04663295 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) — 75.3; 80.9; 5.6 percentage of total readings — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
75.3; 80.9; 5.6 | <0.001 sig |
| SECONDARY Time in Hypoglycemic Range |
0.4; 0.8; 2.2 | — |
| 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) |
16.9; 2.4; 0.1 | — |
| SECONDARY Standard Deviation (SD) of SG in mmol/L |
2.4 | — |
| SECONDARY Standard Deviation (SD) of SG in mg/dL |
43.2 | — |
| SECONDARY Coefficient of Variation (CV) of SG |
30.6 | — |
| SECONDARY Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS) |
42.8; 40.7; -2.1 | — |
| SECONDARY Change of Weight From Baseline to EOS |
61.0; 61.0; 0.1 | — |
| SECONDARY Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop) |
93.5; 6.5 | — |
| SECONDARY Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) |
0.3; 0.4; 0.4; 0.6; 0.7; 0.8 | — |
Eligibility Criteria
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:
- 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.
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:
- 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.)
- 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
Data sourced from ClinicalTrials.gov (NCT04663295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.