Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112343
Other study ID # 2016-08-006-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2017
Est. completion date December 30, 2018

Study information

Verified date April 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.")


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Algorithm-based feedback messages
ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
Personal Health Record
Subjects will save and send their health information to the server via the personal health record app

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (5)

Lead Sponsor Collaborator
Samsung Medical Center Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center, Korea Evaluation Institute of Industrial Technology, Ministry of Trade, Industry & Energy, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24 the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24 Week 24
Secondary the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12 the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12 Week 12
Secondary mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24 mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24 Week 12 and 24
Secondary levels of HbA1c at Week 12 and Week 24 levels of HbA1c at Week 12 and Week 24 Week 12 and Week 24
Secondary lipid profile at Week 12 and Week 24 lipid profile at Week 12 and Week 24 Week 12 and 24
Secondary the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24 the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24 Week 12 and Week 24
Secondary the number of steps during Week 1-12 and Week 13-24 the number of steps during Week 1-12 and Week 13-24 Week 12 and Week 24
Secondary recorded exchange unit by food group recorded exchange unit by food group (grains, meats and protein, fruits, vegetables, dairy, and fats and oils) in each breakfast, lunch, and dinner on 3-day food diary at Week 12 and 24 Week 12 and 24
Secondary daily insulin dose daily insulin dose at Week 12 and Week 24 Week 12 and Week 24
Secondary blood pressure blood pressure at Week 12 and Week 24 Week 12 and Week 24
Secondary body weight body weight at Week 12 and Week 24 Week 12 and Week 24
Secondary lean body mass lean body mass at Week 12 and Week 24 Week 12 and 24
Secondary fat mass fat mass at Week 12 and Week 24 Week 12 and 24
Secondary Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24 Week 12 and 24
Secondary Satisfaction evaluation by DTSQ Satisfaction evaluation by DTSQ at Week 12 and 24 Week 12 and 24
Secondary the number of telephone counselling by diabetes educators the number of telephone counselling by diabetes educators Week 12 and 24
Secondary the number of self-monitoring blood glucose measurements the number of self-monitoring blood glucose measurements Week 12 and 24
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A