Diabetes MellitusICTNCT03112343
Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment
A study testing Algorithm-based feedback messages and Personal Health Record in people with Diabetes Mellitus and Insulin Hypoglycemia, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Insulin Hypoglycemia, Insulin-dependent Diabetes Mellitus
- What is being tested?
- Algorithm-based feedback messages and Personal Health Record
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.")
Read the 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.
- Being tested
- Algorithm-based feedback messages, Personal Health Record
- Keywords
- ICT based clinical trial, Contract research organization (CRO), eCRF, Joint Electronic-institutional review board (eIRB), Centralized monitoring
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm-based feedback messagesDevice
ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
Personal Health RecordDevice
Subjects will save and send their health information to the server via the personal health record app
| Study group | Role | What they receive |
|---|---|---|
| ICT-based intervention | Active comparator | Subjects in the ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention Receives: 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 Receives: Device: Personal Health Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Measured: Week 24
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
Measured: Week 12
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
Measured: Week 12 and 24
levels of HbA1c at Week 12 and Week 24
levels of HbA1c at Week 12 and Week 24
Measured: Week 12 and Week 24
lipid profile at Week 12 and Week 24
lipid profile at Week 12 and Week 24
Measured: Week 12 and 24
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
Measured: Week 12 and Week 24
the number of steps during Week 1-12 and Week 13-24
the number of steps during Week 1-12 and Week 13-24
Measured: Week 12 and Week 24
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
Measured: Week 12 and 24
daily insulin dose
daily insulin dose at Week 12 and Week 24
Measured: Week 12 and Week 24
blood pressure
blood pressure at Week 12 and Week 24
Measured: Week 12 and Week 24
body weight
body weight at Week 12 and Week 24
Measured: Week 12 and Week 24
lean body mass
lean body mass at Week 12 and Week 24
Measured: Week 12 and 24
fat mass
fat mass at Week 12 and Week 24
Measured: Week 12 and 24
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
Measured: Week 12 and 24
Satisfaction evaluation by DTSQ
Satisfaction evaluation by DTSQ at Week 12 and 24
Measured: Week 12 and 24
the number of telephone counselling by diabetes educators
the number of telephone counselling by diabetes educators
Measured: Week 12 and 24
the number of self-monitoring blood glucose measurements
the number of self-monitoring blood glucose measurements
Measured: Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start26 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized in a 1:1 ratio to either the information and communication technology(ICT)-based intervention group or the conventional intervention group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
- Responsible party
- Principal investigator, Sang-Man Jin, Samsung Medical Center
- Investigators
- Sang-Man Jin, MD PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112343
- Sponsor's protocol ID
- 2016-08-006-001
- Acronym
- ICT
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2017
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28720103
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03112343
- Acronym / sponsor ID
- ICT / 2016-08-006-001
- Keywords
- ICT based clinical trial, Contract research organization (CRO), eCRF, Joint Electronic-institutional review board (eIRB), Centralized monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized in a 1:1 ratio to either the information and communication technology(ICT)-based intervention group or the conventional intervention group
| Arm | Type | Receives |
|---|---|---|
| ICT-based intervention | Active comparator | Device: Algorithm-based feedback messages, Device: Personal Health RecordSubjects in the ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention |
| Conventional intervention group | Placebo comparator | Device: Personal Health RecordSubjects in the conventional intervention group will only save and send their health information to the server via the personal health record app |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm-based feedback messagesICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention | Device | ICT-based intervention |
| Personal Health RecordSubjects will save and send their health information to the server via the personal health record app | Device | Conventional intervention group, ICT-based intervention |
Primary outcome
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.
Time frame: 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
17 secondary outcomes
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Time frame: Week 24
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
Time frame: Week 12
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
Time frame: Week 12 and 24
levels of HbA1c at Week 12 and Week 24
Time frame: Week 12 and Week 24
lipid profile at Week 12 and Week 24
Time frame: Week 12 and 24
the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
Time frame: Week 12 and Week 24
the number of steps during Week 1-12 and Week 13-24
Time frame: Week 12 and Week 24
recorded exchange unit by food group
Time frame: Week 12 and 24
daily insulin dose
Time frame: Week 12 and Week 24
blood pressure
Time frame: Week 12 and Week 24
body weight
Time frame: Week 12 and Week 24
lean body mass
Time frame: Week 12 and 24
fat mass
Time frame: Week 12 and 24
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring
Time frame: Week 12 and 24
Satisfaction evaluation by DTSQ
Time frame: Week 12 and 24
the number of telephone counselling by diabetes educators
Time frame: Week 12 and 24
the number of self-monitoring blood glucose measurements
Time frame: Week 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 28720103Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Man Jin, MD PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm-based feedback messages and Personal Health Record in people with Diabetes Mellitus and Insulin Hypoglycemia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.