The investigation on QOL and the effect of hybrid closed loop therapy in patients with type 1 diabetes mellitus

The investigation on QOL and the effect of hybrid closed loop therapy in patients with type 1 diabetes mellitus - HCLQOL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049570

Enrollment

200

Registered

2023-01-05

Start date

2023-01-05

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: HCL group (1) Patients 18 and over years of age at the time of consent. (2) Patients with type 1 diabetes. (3) Patients who have been on SAP therapy using the MiniMed770G system for at least 6 months. (4) Patients who can provide written consent in person. MDI group (1) Patients 18 and over years of age at the time of consent. (2)Patients with type 1 diabetes. (3)Patients who have been on MDI therapy and isCGM for at least 6 months. (4)Patients who can provide written consent in person.

Exclusion criteria

Exclusion criteria: (1)Patients on dialysis. (2)Patients with pregnancy. (3)Patients whom the principal investigator deems inappropriate for this study.

Design outcomes

Primary

Measure	Time frame
PAID(Problem Areas In Diabetes Survey)score	—

Secondary

Measure	Time frame
HbA1c,GA TAR(>250mg/dL),TAR(>180mg/dL),TIR(70-180mg/dL),TBR(<70mg/dL),TBR(<54mg/dL) High sensor glucose alert count, low sensor glucose alert count, TDD(Total Daily Dose of insulin),TBD(total basal insulin dose),TBD/TDD, DTR-QOL(Diabetes Therapy-Related QOL) ITSQ-J (Insulin Treatment Satisfaction Questionnaire in Japanese) CSII-QOL(Continuous Subcutaneous Insulin Infusion-Related Quality-of-Life) Self-administered QOL questionnaire	—

Measure

Time frame

HbA1c,GA TAR(>250mg/dL),TAR(>180mg/dL),TIR(70-180mg/dL),TBR(<70mg/dL),TBR(<54mg/dL) High sensor glucose alert count, low sensor glucose alert count, TDD(Total Daily Dose of insulin),TBD(total basal insulin dose),TBD/TDD, DTR-QOL(Diabetes Therapy-Related QOL) ITSQ-J (Insulin Treatment Satisfaction Questionnaire in Japanese) CSII-QOL(Continuous Subcutaneous Insulin Infusion-Related Quality-of-Life) Self-administered QOL questionnaire

—

Countries

Japan

Contacts

Public ContactYushi Hirota

Kobe University Graduate School of Medicine Department of Internal Medicine Division of Diabetes and Endocrinology

hirota@med.kobe-u.ac.jp078-382-5861

Outcome results