information and communication technology based centralized clinical trial monitoring system for insulin dose adjustment

Conditions: Diabetes Mellitus; Insulin Hypoglycemia; Insulin-dependent Diabetes Mellitus

Summary: this is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary hospitals. there are three follow-up measures; at baseline, post-intervention at week 12, and week 24. subjects are diagnosed as type 1 dm, type 2 dm, and/or post-transplant dm, and initiate or currently use insulin therapy. after the given education on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period, subjects are randomized in a 1:1 ratio to either the ict-based intervention group or the conventional intervention group. subjects in conventional intervention group will save and send their health information to the server via the phr app, whereas those in ict-based intervention group have additional algorithm-based feedback messages. the health information includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of steps. the primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits. this study is based upon work supported by the ministry of trade, industry \& energy (motie, korea) under industrial technology innovation program (no. 10059066, 'establishment of ict clinical trial system and foundation for industrialization.")

this is a 24-week, open, randomized, multi-center ict-based clinical trial conducted in three different hospitals including samsung medical center, kangbuk samsung hospital, and samsung changwon hospital. there are three follow-up measures; at baseline, post-intervention at week 12, and week 24. subjects diagnosed as t1dm, t2dm, and/or post-transplant dm who initiate or currently use insulin therapy will be given education on insulin injection, dose adjustment, and prevention for hypoglycemia and provided at-home measurement device at visit 1 for screening. subjects will receive instructions to check daily glucose levels by home glucose meter, to record insulin regimen and dose, the hypoglycemia diary if blood glucose \ 200 mg/dl three or more times in the morning, and wants to see a doctor during week 1-12. the unscheduled visit to clinic is also allowed to the subjects who have difficulty in insulin dose adjustment despite of two or more unscheduled tele-visit. however, even if this criterion does not apply, patients who initiate insulin or change their regimen (eg, from basal insulin once daily to premixed insulin or multiple dose insulin injections) will be allowed to have additional planned doctor visits prior to visit 3, which is not included in the unscheduled visit, but will be evaluated as scheduled additional visit. the primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.

Eligibility criteria:
inclusion criteria 1. age between 18-69 years 2. diagnosis of t1dm, t2dm, and/or post-transplant dm (post-transplant dm includes both diagnosed t1dm or t2dm before organ transplantation and first diagnosed dm after organ transplantation) 3. initiation or current use of insulin therapy including once-daily basal insulin (including basal insulin only or basal insulin plus rapid-acting insulin), premixed insulin, or nph) 4. most recent hemoglobin a1c (hba1c) ≥7.0% based on the national glycohemoglobin standardization program (ngsp) at least 3 months prior to participation (recent hba1c values measured \<3 months prior to screening are permitted.) 5. available to use smartphone and wireless internet 6. voluntarily write consent to participate in the trial exclusion criteria 1. on insulin pump 2. history of alcohol or drug abuse 1 year prior to participation 3. history of psychological disorder (e.g., schizophrenia, depression, or bipolar disorder) 4. history of severe visual or hearing impairment 5. pregnant 6. any condition, in the investigator's opinion, not suitable for enrollment eligibility.

Keywords: ict based clinical trial contract research organization (cro) ecrf joint electronic-institutional review board (eirb) centralized monitoring