The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin

The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin - The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with a combination of oral antihyperglycemic drugs and basal insulin

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039879

Enrollment

600

Registered

2020-09-11

Start date

2020-08-12

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 2 diabetes

Interventions

None listed

Sponsors

kobe University Graduate School of Medicine Diabetes / Endocrine Internal Science

Lead Sponsor

Yokota Medical Clinic, Kakogawa central city hospital, kita-harima medical center, Kobe City Medical Center West Hospital,Ippanzadanhoujin Kohnankai Kohnanbyouin,National Hospital Organization Kobe Medical Center,National Hospital Organization Hyogo Chuo Hospital, ShinkoHospital, Akashi Medical Center, Takatsuki General Hospital, Chibune General Hospital, STEEL MEMORIAL HIROHATA HOSPITAL, TAKABE CLINIC, Nishiwaki Municipal Hospital, Hyogo Prefectural AWAJI Medical Center, Hyogo Prefectural Kakog

Collaborator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Type 2 diabetic patients treated with combination of oral antihyperglycemic drugs or GLP-1 receptor agonist and basal insulin 2)HbA1c < 12% 3)Patients whose antihyperglycemic drugs and basal insulin have not changed for three monthes 4)Outpatient 5)With regard to participation in this study, patients who gained document consent by their own voluntary intentio

Exclusion criteria

Exclusion criteria: 1)Patients participating in other clinical trials 2)Patients with severe skin disease on the upper arm 3)Patients using other implantable medical devices such as pacemakers 4)Patients taking steroid 5)Cancer patients 6)Patients taking sulfonylureas or glinide 7)Patients trated with bolus insulin 8)Patients using FreeStyle Libre 9)In addition, patients judged inappropriate by the doctor in charge of this study

Design outcomes

Primary

Measure	Time frame
Association between time of hypoglycemic range(min/day) and levels of HbA1c	—

Secondary

Measure	Time frame
Association between hypoglycemic symptons, MEAN, SD/MAGE/CV, time of hyperglycemic range, AUC, TIR, TBR, TAR, and levels of HbA1c	—

Countries

Japan

Contacts

Public ContactYushi Hirota

Kobe University Hospital Department of Internal Medicine, Division of Diabetes and Endocrinology

akane.agbd.3284@gmail.com078-382-5860

Outcome results