Efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patient

Efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patient - multicenter randomized prospective study - - HANABI STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043563

Enrollment

300

Registered

2021-03-10

Start date

2021-03-10

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 Mellitus

Interventions

isCGM (Freestyle Libre) 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)SMBG user of type 2 diabetic patients treated with self-injection therapy (over 6 months treatment) 2)Adaptation for type 2 diabates on the attached document of Freestyle Libre 3)Patients for whom written consent can be obtained (those with capacity to consent)

Exclusion criteria

Exclusion criteria: 1)Contraindication of Freestyle Libre on the attachment document 2)Patients with an HbA1c level of less than 7.0% (20 to 65 years old) and patients with an HbA1c level of less than 7.5% (65 to 75 years old) 3)Mentally handicapped patient unsuitable for study evaluation 4)Pregnant women 5)Poor prognostic patient with malignancy 6)Patient with progressive diabetic retinopathy 7)Less than eGFR 30 ml/min/1.73m2 8)Hemoglobinopathy 9)Exercise restricted patient 10)Patient in treatment with drugs affect blood glucose levels including steroids, anti-cancer drugs, interferon et al 11)Dementia 12)Patients with therapeutic contraindications to the use of Freestyle Libre 13)Patients deemed unsuitable for this study by the researcher in this study

Design outcomes

Primary

Measure	Time frame
Group differences in HbA1c change after 6 months of study	—

Secondary

Measure	Time frame
1)TIR: time in range 2)TBR: time below range 3)TAR: time above range 4)HbA1c (except after 6 months), fasting blood glucose, C-peptide, body weight 5) Within-group changes in TIR goal achievement rates and between-group comparisons 6) HbA1c goal achievement rates and between-group comparisons 7) Within-group changes in the composite endpoint of 5) and 6) and between-group comparisons 8) Changes in psychological and behavioral indicators (DTSQ)	—

Measure

Time frame

1)TIR: time in range 2)TBR: time below range 3)TAR: time above range 4)HbA1c (except after 6 months), fasting blood glucose, C-peptide, body weight 5) Within-group changes in TIR goal achievement rates and between-group comparisons 6) HbA1c goal achievement rates and between-group comparisons 7) Within-group changes in the composite endpoint of 5) and 6) and between-group comparisons 8) Changes in psychological and behavioral indicators (DTSQ)

—

Countries

Japan

Contacts

Public ContactKeishi Mori

Shido Inc. Research Office

info@shido.co.jp03-4500-5075

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026