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

NCT03112343 | Completed DMC

• 1 other identifier: 2016-08-006-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ICT based clinical trial; Contract research organization (CRO); eCRF; Joint Electronic-institutional review board (eIRB); Centralized monitoring

Outcome Measures

Primary Outcomes (1)

• the proportion of patients who reach his/her optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.

  Reaching optimal insulin dose: A.For a patient who uses basal insulin only or basal insulin with pre-meal rapid-acting insulin once per day,1)3 or more fasting blood glucose(FBG) values in the morning within the target range(80-130mg/dL or 100-140 mg/dL) during Week12,2)no nocturnal(11pm-7am) or pre-breakfast hypoglycemia(\<70mg/dL) during Week12,3)variation of basal insulin dose (the difference between the highest and lowest basal insulin dose) of \<10% of mean total basal insulin dose during Week12. B.For a patient who uses MDI at least twice per day, the criteria A plus 4)3 or more days in which correction dose premeal insulin is required less than 3times per day during the Week12,5) no daytime(7am-11pm) hypoglycemia during Week12. C.For a patient who uses premixed insulin or NPH,1)3 or more FBG values in the morning and evening within the target range during Week 12,2) no nocturnal or pre-breakfast hypoglycemia during Week12

  Week 12

Secondary Outcomes (17)

• the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24

  Week 24

• the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12

  Week 12

• mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24

  Week 12 and 24

• levels of HbA1c at Week 12 and Week 24

  Week 12 and Week 24

• lipid profile at Week 12 and Week 24

  Week 12 and 24

Study Arms (2)

ICT-based intervention

ACTIVE COMPARATOR

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

Device: Algorithm-based feedback messages; Device: Personal Health Record

Conventional intervention group

PLACEBO COMPARATOR

Subjects in the conventional intervention group will only save and send their health information to the server via the personal health record app

Device: Personal Health Record

Interventions

Algorithm-based feedback messages DEVICE

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

ICT-based intervention

Personal Health Record DEVICE

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

Conventional intervention group; ICT-based intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18-69 years
• 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)
• 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)
• 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.)
• available to use smartphone and wireless internet
• Voluntarily write consent to participate in the trial

You may not qualify if:

• on insulin pump
• history of alcohol or drug abuse 1 year prior to participation
• history of psychological disorder (e.g., schizophrenia, depression, or bipolar disorder)
• history of severe visual or hearing impairment
• pregnant
• any condition, in the investigator's opinion, not suitable for enrollment eligibility.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator
• Korea Evaluation Institute of Industrial Technology: collaborator
• Daegu Metropolitan City, Korea: collaborator
• ICT Clinical Trial Coordination Center: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Kim G, Bae JC, Yi BK, Hur KY, Chang DK, Lee MK, Kim JH, Jin SM. An information and communication technology-based centralized clinical trial to determine the efficacy and safety of insulin dose adjustment education based on a smartphone personal health record application: a randomized controlled trial. BMC Med Inform Decis Mak. 2017 Jul 18;17(1):109. doi: 10.1186/s12911-017-0507-4.

  PMID: 28720103 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Sang-Man Jin, MD PhD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: randomized in a 1:1 ratio to either the information and communication technology(ICT)-based intervention group or the conventional intervention group

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 13, 2017
• Study Start: September 26, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)