Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment

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.")

Conditions

• Diabetes Mellitus
• Insulin Hypoglycemia
• Insulin-dependent Diabetes Mellitus

Interventions

DEVICE

Algorithm-based feedback messages

ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention

DEVICE

Personal Health Record

Subjects will save and send their health information to the server via the personal health record app

Sponsors & Collaborators

• Ministry of Trade, Industry & Energy, Republic of Korea

  collaborator OTHER_GOV

• Korea Evaluation Institute of Industrial Technology

  collaborator OTHER

• Daegu Metropolitan City, Korea

  collaborator OTHER_GOV

• ICT Clinical Trial Coordination Center

  collaborator OTHER

• Samsung Medical Center

  lead OTHER

Principal Investigators

• Sang-Man Jin, MD PhD · Samsung Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-26

Primary Completion

2018-09-30

Completion

2018-12-30

Countries

• South Korea

Study Locations