Efficacy and Psychological Impact of Advanced Hybrid Closed-Loop for Type 1 Diabetes in Japanese

Efficacy and Psychological Impact of Advanced Hybrid Closed-Loop for Type 1 Diabetes in Japanese - Efficacy of AHCL for Type 1 Diabetes in Japanese

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053373

Enrollment

Registered

2024-02-01

Start date

2024-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)18 years of age or older (2)Patients diagnosed with type 1 diabetes (3)Patients receiving SAP therapy for more than 3 months (4)Patients starting to use AHCL (5)Patients with written informed consent

Exclusion criteria

Exclusion criteria: (1) Patients with cancer (2) Patients receiving systemic steroids (3) Pregnant or lactating women (4) Patients deemed unsuitable as subjects by the principal investigator or research assistant

Design outcomes

Primary

Measure	Time frame
Change from baseline to end of follow-up (at 26 weeks) in the percentage of time that the sensor glucose level was from 70 to 180 mg/dL.	—

Secondary

Measure	Time frame
(1) Baseline and end of follow up data for the following items Percentage of time with sensor glucose levels greater than 181 mg/dL and greater than 251 mg/dL Percentage of time with sensor glucose levels less than 70 mg/dL and less than 54 mg/dL Mean, coefficient of variation, and glucose control indicator values for sensor glucose values Glycemia risk index Average daily insulin dose, average daily bolus insulin dose, and average daily basal insulin dose HbA1c Questionnaire scores (DTSQs, DTSQc, PAID, CSII-QOL, HFS) (2) CGM logging time and AHCL operating time, number of AHCL suspensions (3) Average number of blood glucose measurements per day	—

Measure

Time frame

(1) Baseline and end of follow up data for the following items Percentage of time with sensor glucose levels greater than 181 mg/dL and greater than 251 mg/dL Percentage of time with sensor glucose levels less than 70 mg/dL and less than 54 mg/dL Mean, coefficient of variation, and glucose control indicator values for sensor glucose values Glycemia risk index Average daily insulin dose, average daily bolus insulin dose, and average daily basal insulin dose HbA1c Questionnaire scores (DTSQs, DTSQc, PAID, CSII-QOL, HFS) (2) CGM logging time and AHCL operating time, number of AHCL suspensions (3) Average number of blood glucose measurements per day

—

Countries

Japan

Contacts

Public ContactSatoshi Kubota

Shinshu University Hospital Diabetes, Endocrinology and Metabolism

skubota@shinshu-u.ac.jp+81263354600

Outcome results