JPRN-jRCTs042220048
Completed
Phase 2
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
Jinnouchi Hideaki0 sites100 target enrollmentAugust 3, 2022
Conditionstype 2 diabetes mellitus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- type 2 diabetes mellitus
- Sponsor
- Jinnouchi Hideaki
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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)
Outcomes
Primary Outcomes
Not specified
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