Type 1 Diabetes
Conditions
Interventions
The subjects will undergo regular carbohydrate counting from Week 0 through 4, and receive bolus insulin administration, after 2 weeks of run-in-period, they will undergo simplified carbohydrate count
Sponsors
Hirota Yushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.18 years of age or older 2.Type 1 Diabetes (Diagnosis based on diagnostic criteria of the Japan Diabetes Society) 3.Individuals who use AHCL function in the MiniMed 780G system continuing for more than 6 months 4.Individuals for whom errors in carb counting are less than 20%* 5.Written consent has been obtained from the individual regarding participation in this study *The error in carb counting is calculated after recording meals for three days using the formula:[(Carbohydrate amount estimated by the subject - Carbohydrate amount estimated by the registered dietitian) / Carbohydrate amount estimated by the registered dietitian]x 100 (%)
Exclusion criteria
Exclusion criteria: 1.Individuals who are pregnant, planning to become pregnant within one year, or breastfeeding 2.Individuals who receive oral or intravenous steroids 3.Individuals who undergo maintenance dialysis 4.Individuals who have undergone cancer treatment within the past five years 5.Other than listed above, individuals whom investigators or sub-investigators assess as unsuitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in TIR (70-180 mg/dL) for the last 28 days (noramal carb count) obtained at Week 4 and TIR (70-180 mg/dL) for the last 28 days (simplified carb count) obtained at Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints 1) The change in TITR, TAR, TBR, mean SG, SD, CV, GMI, and GRI for the last 28 days at Week 4 and 10 2) The change in Total daily dose (TDD) of insulin, total daily basal dose (TBD) of insulin, TBD/TDD, total bolus dose, total autobolus dose, number of bolus injections, total autobolus dose/ total bolus dose, and total autobolus dose/TDD for the last 28 days at Week 4 and 10 3) The change in GA at Week 4 and 10 4) The change in QOL assessment at Week 4 and 10: DTR-QOL, PAID, DTSQ, and CSII-QOL 5) The change in insulin pump related information for the last 28 days at Weeks 4 and 10: carbohydrate amount, sensor usage rate, and AHCL function usage rate 6) TIR > 70% achieved at each timepoint at Week 4 and 10 7) TITR > 50% achieved at each timepoint at Week 4 and 10 8) Proportion of individuals who have required minus correction for additional insulin before breakfast for the last 14 days at Week 4 and 10 9) The change in TITR, TAR, TBR, mean SG, SD, CV, GMI, and GRI for the last 14 days at Week 4 and 10 10) Accuracy of carbohydrate counting at Week 4 and 10 Safety Endpoints 1) Serious adverse events (death, hospitalization, and other life-threatening adverse events) 2) Skin problems 3) Severe hypoglycemia 4) Ketosis | — |
Contacts
Public ContactShuichiro Saito
Kobe University Hospital
Outcome results
None listed