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

Not Applicable

Completed

• Conditions: Insulin-dependent Diabetes Mellitus; Diabetes Mellitus; Insulin Hypoglycemia
• Interventions: Device: Algorithm-based feedback messages; Device: Personal Health Record

• Registration Number: NCT03112343
• Lead Sponsor: Samsung Medical Center

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.")

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-09
• Study First Posted: 2017-04-13
• Study Start: 2017-09-26
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	Week 12	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

Secondary Outcome Measures

Name	Time	Method
levels of HbA1c at Week 12 and Week 24	Week 12 and Week 24	levels of HbA1c at Week 12 and Week 24
lipid profile at Week 12 and Week 24	Week 12 and 24	lipid profile at Week 12 and Week 24
Satisfaction evaluation by DTSQ	Week 12 and 24	Satisfaction evaluation by DTSQ at Week 12 and 24
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12	Week 12	the proportion of patients who reach HbA1c \<7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
the number of steps during Week 1-12 and Week 13-24	Week 12 and Week 24	the number of steps during Week 1-12 and Week 13-24
daily insulin dose	Week 12 and Week 24	daily insulin dose at Week 12 and Week 24
blood pressure	Week 12 and Week 24	blood pressure at Week 12 and Week 24
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring	Week 12 and 24	Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24
the number of telephone counselling by diabetes educators	Week 12 and 24	the number of telephone counselling by diabetes educators
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 24
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24	Week 12 and 24	mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
recorded exchange unit by food group	Week 12 and 24	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
lean body mass	Week 12 and 24	lean body mass at Week 12 and Week 24
fat mass	Week 12 and 24	fat mass 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	the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
the number of self-monitoring blood glucose measurements	Week 12 and 24	the number of self-monitoring blood glucose measurements
body weight	Week 12 and Week 24	body weight at Week 12 and Week 24

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of