An Exploratory Study of Dietary Management Apps in Adults with Type 2 Diabetes

JRCT ID: jRCTs032220491

Registered date:07/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetic
• Date of first enrollment: 07/12/2022
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Based on the target HbA1c calculated by Glucose Flight (application software), the doctor adjusts the insulin unit through face-to-face consultation and remote insulin guidance on the app, and adjusts to reach the target blood sugar level.

Outcome(s)

• Primary Outcome: Comparison of the amount of change in HbA1c from week 8 before the treatment period to week 0 and from week 0 of the treatment period to week 8

Secondary Outcome

Efficacy
1) Comparison of changes in the following items between 2 months from 8 weeks to 0 weeks before the treatment period and 2 months from 0 weeks to 8 weeks
-Physical examination (blood pressure,pulse,weight, BMI,waist circumference)
-General blood test (white blood cells,red blood cells,platelets,hemoglobin,hematocrit value)
-Biochemical test
-Urinalysis (urine protein qualitative,urine ketone bodies)
2) Changes in lipid metabolism (total cholesterol,TG,HDL-C,LDL-C)comparison
3) Change in QOL at the time of informed consent (week -2) and at the end of the treatment period (week8 or discontinuation)
4) Changes in the following parameters from week 0 to week 8
Ambulatory glucose profile (AGP),Postprandial Glucose Profile (PGP),Glucose management indicator (GMI),average blood sugar,Blood glucose level,mean, time above range (TAR), time in range (TIR), time below range (TBR),blood glucose variability index
5) Comparison of meal scores for each diet, amount of changes in HbA1c, glycoalbumin, and GMI, from week 0 to week 8
6) Frequency of insulin adjustment in telemedicine
Usability
1) Usefulness of Glucose Flight
Comparison of teaching time before and during glucose flight
Safety
1) Occurrence of such as adverse events, diseases and malfunctions
2) Number of occurrences of hypoglycemia, number of occurrences of severe hypoglycemia

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who are using insulin in the diagnosis of type 2 diabetes
2) Patients with HbA1c >=7.0% and <=10.0% at -8 weeks (retrospective data)
3) Body Mass Index (BMI): Patients with BMI of more than 18.5 kg/m2 and less than 35.0 kg/m2
4) Age at the time of obtaining consent: Patients over 20 years of age
5) Gender: Regardless
6) Patients for whom written consent has been obtained to participate in this study by their own free will

Exclude criteria

1) Patients with type 1 diabetes
2) Patients with steroid diabetes
3) Pregnant patients
4) Patients with diabetic nephropathy Stage 3-5
5) Patients currently diagnosed with cancer and undergoing treatment
6) Patients with hemoglobin less than 11.0 g/dL within 1 year before informed consent
7) Patients who received a blood transfusion within one month
8) Patients who plan to receive blood transfusions during clinical trials
9) Furthermore, patients whose participation in this study is inappropriate by the principal or sub investigator

Related Information

• Primary Sponsor: Ishii Hideto
• Secondary Sponsor: THE PHAGE, Inc.