Evaluation of short-term changes in glycemic variability indices after switching from daily to once-weekly basal insulin

Evaluation of short-term changes in glycemic variability indices after switching from daily to once-weekly basal insulin: A multicenter, exploratory, prospective single-arm observational study - Evaluation of changes in glycemic variability indices after switching from daily to once-weekly basal insulin

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058340

Enrollment

Registered

2025-07-02

Start date

2025-05-28

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: Patients with type 2 diabetes who have been treated for at least two weeks with once-daily basal insulin and are using continuous glucose monitoring (CGM).

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) Gestational diabetes 3) Diabetic ketoacidosis 4) Inappropriate as study subjects by the principal investigator

Design outcomes

Primary

Measure	Time frame
The change in 24-hour average blood glucose levels between the initial and second administration of insulin icodec.	—

Secondary

Measure	Time frame
Assessment -1: Pre-switching to insulin icodec Assessment 1: After first dose of insulin icodec Assessment 2: Before second dose of insulin icodec Assessment 3: After second dose of insulin icodec 1) Various CGM metrics will be assessed between Assessment 1 and Assessment 3, including: Time in Range (TIR), Time Below Range (TBR), Time Above Range (TAR), Mean Amplitude of Glycemic Excursions (MAGE), Coefficient of Variation (%CV) for intraday glucose variability, Mean of Daily Differences (MODD) for inter day glucose variability. 2) Changes in various CGM metrics between Assessment 1 and Assessment 2. 3) Changes in various CGM metrics between Assessment 2and Assessment 3. 4) Changes in various CGM metrics from Assessment -1 to Assessments 1 through 3 (if pre-switch CGM data are available). 5) Daily intraday glycemic variability during each assessment period. 6) Changes in weekly insulin dose. 7) Changes in the CGM metrics stratified by insulin dose at switching.	—

Measure

Time frame

Assessment -1: Pre-switching to insulin icodec Assessment 1: After first dose of insulin icodec Assessment 2: Before second dose of insulin icodec Assessment 3: After second dose of insulin icodec 1) Various CGM metrics will be assessed between Assessment 1 and Assessment 3, including: Time in Range (TIR), Time Below Range (TBR), Time Above Range (TAR), Mean Amplitude of Glycemic Excursions (MAGE), Coefficient of Variation (%CV) for intraday glucose variability, Mean of Daily Differences (MODD) for inter day glucose variability. 2) Changes in various CGM metrics between Assessment 1 and Assessment 2. 3) Changes in various CGM metrics between Assessment 2and Assessment 3. 4) Changes in various CGM metrics from Assessment -1 to Assessments 1 through 3 (if pre-switch CGM data are available). 5) Daily intraday glycemic variability during each assessment period. 6) Changes in weekly insulin dose. 7) Changes in the CGM metrics stratified by insulin dose at switching.

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Countries

Japan

Contacts

Public ContactHiroshi Nomoto

Asahikawa Medical University Hospital Department of diabetology and endocrinology

hnomoto@asahikawa-med.ac.jp0166-65-2111

Outcome results