Glucose management impact of "asken medical system" in patients with type 2 diabetes.

JRCT ID: jRCTs052220099

Registered date:27/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 17/11/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Medical nutrition therapy with "asken medical system"

Outcome(s)

• Primary Outcome: Cange of time in range (%) at 4 weeks

Secondary Outcome

1)Change of body weight
2)Change of clinical data (HbA1c, glycated albumin, LDL, HDL, urine protein, urine urea nitrogen)
3)Time above range (>=180mg/dl), Time below range (<70mg/dl), mean glucose
4)Dietary intake at 4th week (Intervention group only)

Key inclusion & exclusion criteria

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

Include criteria

1) Type 2 diabetes
2) Diabetic nephropathy stage 1 or 2
3) Aged 20 y.o. or older
4) HbA1c >= 7.0%
5) Mobile device user
6) Written informed consent

Exclude criteria

1) Using application assessing dietary intake
2) Pregnant or suspected to be pregnant
3) Breastfeeding
4) Less than 84 days after diagnosed with diabetes
5) Continuous administration of steroids
6) eGFR < 45ml/min/1.73cm2
7) Chronic pancreatitis or pancreatic cancer
8) Liver cirrhosis
9) Decompensated heart failure
10) Drug or alcohol dependence
11) Unstable mental disease
12) Malignant tumor
13) Comorbidity affecting primary outcome
14) Inappropriate for inclusion in the study

Related Information

• Primary Sponsor: Kawashima Sachiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development