Type 2 diabetes
Conditions
Interventions
Standard SMBG (Control)
Using a blood glucose meter with color display indicating blood glucose level in color code
Marking color circles on their SMBG record in case of hyperglycemia and hypoglycemia
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients with T2DM who have been treated with insulin or GLP-1 receptor agonist and perform SMBG 2) Subjects between 20 and 80 years old 3) HbA1c value is over 6.5% and under 10.0%(JDS) 4) Subjects who can diet and/or exercise 5) Subjects who can give written consent
Exclusion criteria
Exclusion criteria: 1) Subjects under 20 years old and over 81 2) Diabetes duration less than 1 year 3) Subjects who initiated treatment with insulin or GLP-1 receptor agonist, or changed the type of insulin or GLP-1 receptor agonist within the last 4 months 4) Subjects who cannot do SMBG by themselves 5) Subjects with impaired vision or synesthesia 6) Subjects who have difficulty with comprehension, psychiatric disease or procedural problems 7) Subjects who have severe heart, hepatic or renal disease 8) Subjects who have abnormal hemoglobin 9) Subjects who are scheduled for hospitalization or move within 6 months 10) Subjects who are not permitted to participate in this trial by attending doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c level from baseline to 6 months after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| A) difference in changes in score of the following questionnaires; 1) Instrument of Diabetes Self-Care Agency(IDSCA) 2) The Summary of Diabetes Self-Care Activities Measure(SDSCA) 3) abridged version of Profile of Mood States(POMS) B) ratio of the following dates; 4) occurrence of change in the dosage and type of insulin/GLP-1 receptor agonist 5) dropout by the discontinuing insulin/GLP-1 receptor agonist treatment or hospitalization C) 6) change in continuance rate of SMBG D) differences in changes in the following levels from baseline to 1 and 2 years; 7) HbA1c levels 8) blood pressure 9) low-density lipoprotein cholesterol levels 10) body weight | — |
Countries
Japan
Contacts
Public ContactAkiko, NISHIMURA
Graduate School of Medicine, Kyoto University Department of Human Health Sciences
Outcome results
None listed