None listed
Conditions
Interventions
Medical Device : After enrollment, the subject should do as follows
Dexcom G6 12weeks
EOPatch Insulin Pump 12weeks
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female over the age of 19 2) Those who have been diagnosed with type 1 diabetes for at least 6 months prior and who have used MDI (Multiple Daily Injection) or insulin pump for more than 3 months. 3) Those who have a type 1 diabetes with HbA1c less than 7.5% recently. 4) Those who are judged to be able to manage their diabetes through insulin administration and glucose monitoring based on the assessment of the Investigator at the screening visit. 5) Those who have voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those diagnosed with other diabetes such as gestational diabetes and type 2 diabetes (T2D) 2) Those who have been hospitalized with a history of diabetic ketoacidosis (DKA) within 12 weeks (= 12 weeks) prior to the screening visit. 3) Those who received emergency treatment or were hospitalized for severe hypoglycemia (Glucose 3 times the upper limit of normal) 8) Those who have gastrointestinal disorders such as repeated diarrhea, vomiting, and severe gastroparesis. 9) Those who have pregnant and breast feeding or expecting to be pregnant. 10) Those who have variable insulin requirements (pre-operative, severe trauma, feverish infections, etc.). 11) Those who have Allergic to acrylic adhesive tape. 12) Excessive alcohol consumption (=420 g/week, about 7 bottles/week of soju, 1 bottle/day) or alcoholics. 13) Those who engaged in dangerous work, such as working in a high position. 14) Those who have difficulty using Investigational devices for clinical trials due to allergies to insulin (Humalog, Novo Rapid) or acrylate-based skin adhesives. 15) Those with unawareness of severe hypoglycemia. 16) Anyone who unfit to participate in clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range within the target blood glucose range* for 24 hours when EOPatchM is applied compared to the baseline period (4 weeks before baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Ratio (%) of time according to glucose concentration when EOPatchM is applied compared to the basal period (4 weeks before the baseline) ;? Glucose variability when EOPatchM is applied compared to the base period (4 weeks before the baseline) b. Glucose coefficient of variation (CV) (%) c. Standard deviation of glucose (SD) (mg/dL);? Median usage time per patch for 12 weeks after EOPatchM application after baseline;safety evaluation ;? Glucose (mg/dL) change at 4 and 12 weeks of EOPatchM application compared to the baseline period (4 weeks before baseline);? HbA1c (%) change at 4 weeks and 12 weeks after EOPatchM application compared to the baseline period (4 weeks before baseline);? Insulin dose when EOPatchM is applied compared to the baseline period (4 weeks before baseline) a. Changes in Total Daily Dose (TDD) b. Changes in total daily bolus dose c. Changes in total daily basal dose | — |
Countries
Korea, Republic of
Contacts
Public ContactJaehyeon Kim
Samsung Medical Center
Outcome results
None listed