Observational study for the frequency of nocturnal hypoglycemia with switching SGLT2 inhibitors.

Observational study for the frequency of nocturnal hypoglycemia with switching SGLT2 inhibitors. - Nocturnal hypoglycemia with switching SGLT2 inhibitors.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059559

Enrollment

Registered

2025-11-01

Start date

2025-11-01

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 years or older at the time of the agreement 2) Within two to ten-weeks period after switching SGLT2 inhibitors. 3) Obtaining written consent for the participation in this study

Exclusion criteria

Exclusion criteria: 1) Changing the diabetic medicine except SGLT2 inhibitor after the hypoglycemia confirmation of the former SGLT2 inhibitor 2) Judging to be inappropriate for study entry from medical grounds by physicians 3) Not obtaining written consent for the participation in this study

Design outcomes

Primary

Measure	Time frame
The absolute and relative changes in nocturnal Time Below Range (TBR, <70 mg/dL) before and after switching SGLT2 inhibitors.	—

Secondary

Measure	Time frame
Changes and change rates in nocturnal TIR (Time in Range, 70-180 mg/dL) and TAR (Time Above Range, >180 mg/dL) Changes and change rates in daily TBR, TIR, and TAR Changes and change rates in daytime TBR, TIR, and TAR Changes and change rates in mean glucose, GMI (Glucose Management Indicator), and glycemic variability Duration of hypoglycemia	—

Countries

Japan

Contacts

Public ContactTomoyasu Oda

Iwate Medical University Divisions of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

toda@iwate-med.ac.jp+81-19-651-5111

Outcome results