Efficacy and Psychological Effects of MiniMed 770G (Hybrid Closed-loop system) in Patients with Type 1 Diabetes
Not Applicable
- Conditions
- Type 1 diabetes
- Registration Number
- JPRN-UMIN000047394
- Lead Sponsor
- Shinshu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with cancer (2) Patients on steroid treatment (3) Persons deemed inappropriate by the Principal Investigator or Research Assistants
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in sensor glucose level from 70 to 180 mg/dL of time at CGM between baseline and end of observation (after 24 weeks of switching).
- Secondary Outcome Measures
Name Time Method (1) Change in each of the following items from baseline to the end of observation (after 24 weeks of changeover) HbA1c Percentage of time that sensor glucose level is higher than 181 mg/dL and higher than 251 mg/dL at CGM. Percentage of time that sensor glucose level is less than 70 mg/dL and less than 54 mg/dL at CGM. Average sensor glucose level and coefficient of variation during the period of CGM Number of hypoglycemia alerts and hyperglycemia alerts Average daily insulin dose and average daily basal insulin dose Scores of various questionnaires (CSII-QOL, DTSQ, PAID) (2) Amount of change in the percentage of HbA1c less than 7% achieved between baseline and the end of observation (after 24 weeks of switching) (3) Time of wearing CGM and using Hybrid closed-loop system