Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061964) titled 'Observational Study on Performance Evaluation of Insulin Dose Decision Support System for People with Type 1 Diabetes' on June 22.

Study Type: Observational

Primary Sponsor: Institute - The Jikei University School of Medicine

Condition: Condition - Type 1 diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether the reference values for insulin doses calculated by the investigational device are within a clinically acceptable range compared to the insulin doses prescribed by diabetologists, using clinical data from patients with type 1 diabetes on multiple daily injection therapy. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 115

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 04 Day Date of IRB - 2025 Year 11 Month 20 Day Anticipated trial start date - 2026 Year 02 Month 25 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070906

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