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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

99

28.0% female and 72.0% male, age 63.2+-11.4 years, body weight 66.27+-13.68 kg, BMI 24.47 +-3.66 kg/m2, height 164.01+-9.96 cm, abdominal circumference 88.67+-10.26 cm, pulse rate 77.1+-11.2 bpm, systolic blood pressure 125.3+-12.4 mmHg, and diastolic blood pressure 72.6+-8.5 mmHg. In addition, 96.8% of the subjects were receiving drug therapy for diabetes, 57.0% diet therapy, 63.4% exercise therapy. 98.8% of subjects had complications including hypertension (52.7%), dyslipidemia (87.1%), hyperuricemia (5.4%), nerve disorder (2.2%), and diabetic retinopathy(5.4%)

Of the 99 subjects who consented to the study, since one dropped out due to screening failure, a total of 98 subjects were randomly assigned. A total of 92 subjects (the Intervention group: 44, the nonIntervention group: 48) completed the study.

One "medical device use site pain" was developed in one subject assigned to the intervention group. It was relieved after 8 days of onset, and recovery was confirmed after 39 days of onset. The same event did not occur during subsequent blood draws.

Primary endpoint: (1) The change in GA value from baseline to last observation day showed a significant decrease in the intervention group compared to the nonintervention group. (2) The changes in calorie intake from baseline to last observation day showed a decrease in the intervention group compared to the non-intervention group, but there was no statistically significant difference between the two groups. (3) The change in physical activity (calorie consumption) from baseline to last observation day showed a significant decrease in the intervention group compared to the non-intervention group. Secondary endpoints: (1) The change in HbA1c from baseline to last observation day showed a significant decrease in the intervention group compared to the non-intervention group. (2) The change in body weight from baseline to last observation day showed a significant decrease in the intervention group compared to the nonintervention group. (3) The change in BMI from baseline to last observation day showed a significant decrease in the intervention group compared to the nonintervention group. (4) The change in abdominal circumference from baseline to last observation day showed a significant decrease in the intervention group compared to the nonintervention group. (5) The change in the total score of Self-efficacy scale for diabetes self-care from baseline to last observation day showed a significant decrease in the intervention group compared to the non-intervention group. (6) The changes in the total score of Exercise Self-efficacy scale for diabetes self-care from baseline to last observation day showed a decrease in the intervention group compared to the non-intervention group, but there was no statistically significant difference between the two groups.

Patients with type 2 diabetes mellitus were studied to evaluate whether monitoring glycoalbumin (GA) levels through weekly self-monitoring of blood samples would motivate behavioral change toward drug therapy, diet, and exercise. Results showed that the intervention method in this study motivated behavioral change and significantly reduced GA, HbA1c, body weight, BMI, and abdominal circumference compared to the non-intervention group.

May. 16, 2024

May. 16, 2024

https://link.springer.com/article/10.1007/s13300-024-01599-2

No

(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.

https://jrct.niph.go.jp/latest-detail/jRCTs042220048

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

July. 27, 2022

none