Type 2 diabetic
Conditions
Interventions
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
Sponsors
Ishii Hideto
THE PHAGE, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHideto Ishii
Asano clinic
Outcome results
None listed