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The digital intervention of a glycated albumin (GA) self-monitoring system for patients with type 2 diabetes: a randomized, open-label, non-intervention group controlled, single-center clinical study

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

Jinnouchi Hideaki

Jinnouchi Hospital

6-2-3, Kuhonji Chuo-ku, Kumamoto-shi, Kumamoto

ct@jinnouchi.or.jp

Yoshida Akira

Jinnouchi Hospital

6-2-3, Kuhonji Chuo-ku, Kumamoto-shi, Kumamoto

+81-96-363-0011

ct@jinnouchi.or.jp

Complete

Aug. 03, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

(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

(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

Both

type 2 diabetes mellitus

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.

type 2 diabetes mellitus

digital intervention, glycated albumin, type 2 diabetes mellitus, clinical study, self-monitoring

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

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

+81-562-93-2865

Yes

(1) Case Report Form (paper): The principal investigator will keep the original and submit the PDF file to the Data Management Officer. (2) Questionnaires(paper): Research subjects shall submit to the investigators, and the investigators or research staff shall keep the original and submit the PDF file to the data management. (3) GA measurement results (electronic file): The GA test agency will submit the subject identification code, date of blood collection, and measurement results to the data management in an electronic file. (4) Data set for analysis and analysis report (electronic file): The data management prepares and submits the data set for analysis to the statistical analyst. The statistical analyst submits the report to the principal investigator. (5) Summary report (electronic file): Prepared and finalized under the supervision of the principal investigator.

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