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An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes

An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes - Positive2SMBG Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035349
Enrollment
200
Registered
2019-01-01
Start date
2017-11-01
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

Patients in intervention group were able to have doctors&#39
instruction with SMBG data-management system (HR Joint Simle Data Vision), a SMBG readings analyzer using a software that provides comprehensive summary statistics, listings and graphical spots of blo

Sponsors

Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients included 1) those with T2D aged 20 years or older and younger than 75 years, 2) those using SMBG for more than 3 months; 3) those with HbA1c 7.0 % or higher and lower than 11.0 %; 4) those capable of answering the questionnaires used in the present study; and 5) those receiving insulin and/or GLP-1 receptor agonist (GLP-1RA) as SMBG is allowed for those using injectables under the Japanese national health insurance coverage.

Exclusion criteria

Exclusion criteria: Patients were excluded if they were 1) susceptible to dementia and/or psychological and/or psychiatric disorders; 2) receiving only GLP-1RA as an injection therapy; or 3) considered to be ineligible for this study by physicians-in-charge.

Design outcomes

Primary

MeasureTime frame
Primary end points of this study were change in HbA1c levels from baseline to 6-month and change in DTR-QOL score from baseline to 6-month.

Secondary

MeasureTime frame
Secondary outcomes were included as follows: change in body weight; SMBG frequency; change in insulin doses; changes in scores of the original SMBG questionnaire.

Countries

Japan

Contacts

Public ContactNagaaki Tanaka

Kansai Electric Power Medical Institute Yutaka Seino Distinguished Center for Diabetes Research

nagaakitanaka@nifty.com+81-6-6458-5821

Outcome results

None listed

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