Type 1 diabetes
Conditions
Interventions
None listed
Sponsors
The Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with type 1 diabetes on multiple daily injection therapy using only rapid-acting insulin analogs and long-acting insulin analogs (insulin glargine, insulin degludec, insulin detemir). (2) Patients who have been using a CGM for 24 weeks or longer at the time of Visit 3. (3) Patients who are 18 years of age or older at the time of Visit 3. (4) Patients who are able to provide written informed consent based on their own free will after understanding the contents of the explanatory document.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with type 2 diabetes, latent autoimmune diabetes in adults (LADA), gestational diabetes, or other specific types of diabetes other than type 1, or patients prescribed insulin for purposes other than glycemic control. (2) Patients using oral hypoglycemic agents other than SGLT2 inhibitors or alpha-glucosidase inhibitors. (3) Patients who have had SGLT2 inhibitors or alpha-glucosidase inhibitors newly added, dose-adjusted, or discontinued, or who have changed their CGM device during the CGM measurement period used for evaluation. (4) Patients who have experienced severe hypoglycemia within 6 months prior to Visit 1, or have an HbA1c of 9% or higher at Visit 3. (5) Patients who determine their insulin dosage based on a carbohydrate-to-insulin ratio. (6) Patients who are prescribed a once-weekly long-acting insulin analog injection. (7) Patients using two or more types of bolus insulin products. (8) Patients receiving basal insulin twice daily. (9) Patients whose insulin doses are adjusted in 0.5-unit increments. (10) Patients for whom the collected CGM data measurement time is less than 70% of the 28-day evaluation period or who have other specified missing input data. (11) Patients who did not have their body weight measured between Visit 1 and Visit 3. (12) Patients with or suspected of having diabetic gastroparesis. (13) Patients with advanced diabetic autonomic neuropathy. (14) Patients with or suspected of having pre-proliferative or proliferative diabetic retinopathy. (15) Patients with concomitant diseases or receiving treatments that affect glycemic control. (16) Any other patients whom the investigator deems unsuitable for participation in the study or whose condition may affect the performance evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the accuracy rate per prescription, where a "correct" case is defined as the difference between the reference insulin dose calculated by the investigational device and the insulin dose prescribed by a diabetologist being within an acceptable range for bolus insulin (morning, noon, evening) and basal insulin. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of total insulin doses 2. Accuracy rate per patient 3. Evaluation of glucose profiles | — |
Countries
Japan
Contacts
Public ContactKenta Niibe
TERUMO CORPORATION R&D Department, Life Care Solutions Division, Medical Care Solutions Company
Outcome results
None listed