The digital intervention of a glycated albumin (GA) self-monitoring system for patients with type 2 diabetes

JRCT ID: jRCTs042220048

Registered date:03/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 03/08/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Study subjects assigned to the intervention group will have GA measured once a week and will record daily behavioral assessments of treatment goals on the application.
Patients assigned to the non-intervention group will continue to receive conventional medical care and treatment.

Outcome(s)

Primary Outcome

1) Glycoalbumin (GA)
2) Energy intake and nutrient composition
3) Physical activity level

Secondary Outcome

1) HbA1c
2) Bodyweight
3) BMI
4) Abdominal circumference
5) Self-efficacy scale for diabetes self-care
6) Exercise self-efficacy scale for diabetes self-care

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who meet the diagnostic criteria for type 2 diabetes mellitus of the Japan Diabetes Society
(2) Patients whose HbA1c measured on the date of consent is 7.0 or higher and 9.0 or lower
(3) Patients who understand the contents of the consent document describing the purpose and methods of the study and agree in writing to participate in the study.
(4) Patients who are 20 years of age or older at the time consent is obtained
(5) Patients who have a smartphone that can use the application

Exclude criteria

(1) Patients on insulin therapy
(2) Patients on GLP-1 injection therapy
(3) Patients under inpatient care
(4) Patients with confirmed or suspected type 1 diabetes
(5) Patients whose HbA1c level has changed 0.8% or more in the 2 visits prior to obtaining consent and whose symptoms have not stabilized
(6) Patients who have undergone a change in drug therapy in the 2 months prior to obtaining consent and whose therapeutic response has not stabilized
(7) Patients who have difficulty or prohibit from following diet or exercise therapy due to other medical conditions
(8) Severely obese patients (BMI > 35)
(9) Patients with diseases or conditions known to cause a discrepancy between GA and blood glucose levels (hyperthyroidism, nephrosis, ascites (peritoneal dialysis), steroid diabetes, high BMI, hypothyroidism, liver cirrhosis, hyponutrition)
(10) Patients with concomitant diseases that affect HbA1c test values (abnormal hemoglobinemia, hemolytic anemia, bleeding disorders, renal failure, patients receiving erythropoietin)
(11) Patients with inadequate responses to required questionnaires
(12) Patients with difficulty in self finger-prick blood sampling

Related Information

• Primary Sponsor: Jinnouchi Hideaki
• Secondary Sponsor: Provigate, Inc.
• Source(s) of Monetary Support: AMED: Japan Agency for Medical Research and Development