Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment
Condition: Diabetes Mellitus; Insulin Hypoglycemia; Insulin-dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

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.")
    

Detailed description: 
      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 <70 mg/dL
      or a hypoglycemic event occurs in the apps, and to synchronize data for automatically
      transferring to system. Subjects who synchronized their information more than once during 1
      week of run-in period will be selected into clinical trial and randomly assigned to either
      ICT-based intervention group or conventional intervention group at a ratio of 1:1. After the
      randomization, at Week 1, diabetes educators provide telephone counselling for re-instructing
      insulin dose adjustment and for re-confirming their use of at-home measurement device and PHR
      apps at Visit 2 (televisit). Subjects in ICT-based intervention group will have
      algorithm-based feedback messages when their glucose levels are out of ranges, in addition to
      recording, saving and sending their data to the server via the PHR app, and those in
      conventional intervention group will only record, save and send their data to the server via
      the PHR app. Investigators examine the saved health information such as levels of blood
      glucose, insulin dose, details on hypoglycemia recorded in hypoglycemia diary, food diary,
      and number of steps transferred through PHR apps. At each clinical visit, anthropometric
      parameters, current medication use including types of insulin, insulin dose, and other
      glucose-lowering agents, vital signs, body composition, and questionnaire for satisfaction
      investigation are examined face-to-face, and blood tests are performed. The unscheduled visit
      to clinic could be applied if a subject has one or more severe hypoglycemia (requiring other
      help for recovery) during the study period, or hypoglycemia (<70 mg/dL) twice or more times
      per week, or fasting 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.
    

Intervention name(s): Algorithm-based feedback messages; Personal Health Record
Intervention type(s): Device; Device
Intervention description(s): ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention; Subjects will save and send their health information to the server via the personal health record app
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized in a 1:1 ratio to either the information and communication technology(ICT)-based intervention group or the conventional intervention group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICT based clinical trial; Contract research organization (CRO); eCRF; Joint Electronic-institutional review board (eIRB); Centralized monitoring