Diabetes Mellitus Clinical Trial
— ICTOfficial title:
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
Verified date | April 2019 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.")
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
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 |
Korea, Republic of,
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 |
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