Type 1 Diabetes MellitusEducationNCT03794934
Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
A study testing Structured Education for new glucose management devices in people with Type 1 Diabetes Mellitus, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved and highly recommended in the treatment of type 1 diabetes patients worldwide, and related technology development and market are growing rapidly. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Structured Education for new glucose management devices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2019to 31 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old - under 70 years old patients with Type 1 diabetes
- Those who plan to use CGM G5
- Patients who consented to use CGM G5 in conjunction with Clarity
- Those who are using multiple insulin injections or insulin pumps for at least 3 months
- Those whose fasting c-peptide <0.6 ng / dL, or stimulated c-peptide <1.8 ng / dL
- Those with a glycated hemoglobin of 7.0% or more within the last 3 months
Show all 9Show fewer
- Those who have never used a CGM for more than a month
- For women of childbearing age, those who agree to use appropriate contraception during the trial
- Those who voluntarily signed the agreement after the explanation of the clinical trial
Who cannot join
- Those with a history of severe hypoglycemia and acute ketoacidosis within the last 3 months
- Patients with chronic renal function greater than or equal to stage 4 (estimated glomerular filtration rate [assessed by MDRD (modification of diet in renal disease] <30 )
- Patients with acute myocardial infarction, unstable angina, coronary artery disease or stroke within the last 3 months
- Patients with adrenal insufficiency, pituitary dysfunction, medically uncontrolled hyperthyroidism or hypothyroidism
- Those taking medications that can affect the glucose metabolism (eg, corticosteroids, immunostimulants, etc.)
- Pregnant and lactating women
- A person who is deemed unsuitable for participation in clinical trials by examiners
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jae Hyeon Kim, M.D.,Ph. D, 82-2-3410-1580, jaehyeonmd.kim@samsung.com
About this study
Official title: Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved and highly recommended in the treatment of type 1 diabetes patients worldwide, and related technology development and market are growing rapidly.
In order to maximize the medical and socioeconomic effects of the latest blood glucose devices including CGM and insulin pump, structured education is necessary. In this study, we will develop patient-oriented structured education for patients with type 1 diabetes mellitus when applying CGM, and we will assess the efficacy of this education protocol for patients with type 1 diabetes using CGM.
Read the detailed description
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose level is not well controlled, and who are undergoing multiple daily insulin injection therapy or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal continuous glucose levels for 1 week (window period of 2 week).
These 50 patients are 1:1 randomly assigned to 2 groups including control group and intervention group. Control group (n=25) applied CGM without structured education and after 3 months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected. As a sequential extension clinical trial, those 25 patients in control group are provided structured education, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected.
In Intervention group (n=25), structured education program is provided for each patient from the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Structured Education for new glucose management devices
- Keywords
- Type 1 Diabetes Mellitus, Continuous Glucose Monitoring, Insulin pump, Structured Education
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Education for new glucose management devicesBehavioural
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Without structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply Receives: Behavioral: Structured Education for new glucose management devices |
| Intervention | Active comparator | provide structured education when applying CGM for 3 months Receives: Behavioral: Structured Education for new glucose management devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in target range 70-180 mg/dL
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Secondary outcomes (13)
Percentage of time in level 2 hypoglycemia (<54mg/dL)
Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hyperglycemia (>180mg/dL)
Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hyperglycemia (>250mg/dL)
Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as coefficient of variance (CV)
Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as standard deviation (SD)
Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Mean glucose by continuous glucose monitoring system
Mean glucose by continuous glucose monitoring system
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
HbA1C
HbA1C
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
glycated albumin
glycated albumin
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Personalized education time for each patient
Personalized education time for each patient
Measured: baseline (intervention group) and 3months (for extension study in control group)
Frequency of hypoglycemia
Frequency of hypoglycemia
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Adverse event
Adverse event occurred
Measured: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
Measured: 6months (for extension study in control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start26 Feb 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Type 1 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
- CGM apply followed by structured education of CGM
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hyeon Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794934
- Sponsor's protocol ID
- 2018-12-108
- Acronym
- Education
- Status last verified
- Mar 2019
- First submitted
- 4 Jan 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoo JH, Kim G, Lee HJ, Sim KH, Jin SM, Kim JH. Effect of structured individualized education on continuous glucose monitoring use in poorly controlled patients with type 1 diabetes: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Feb;184:109209. doi: 10.1016/j.diabres.2022.109209. Epub 2022 Jan 19.
PubMed 35065101
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03794934
- Acronym / sponsor ID
- Education / 2018-12-108
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Continuous Glucose Monitoring, Insulin pump, Structured Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Jan 2019 (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.
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved and highly recommended in the treatment of type 1 diabetes patients worldwide, and related technology development and market are growing rapidly.
In order to maximize the medical and socioeconomic effects of the latest blood glucose devices including CGM and insulin pump, structured education is necessary. In this study, we will develop patient-oriented structured education for patients with type 1 diabetes mellitus when applying CGM, and we will assess the efficacy of this education protocol for patients with type 1 diabetes using CGM.
Detailed description
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose level is not well controlled, and who are undergoing multiple daily insulin injection therapy or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal continuous glucose levels for 1 week (window period of 2 week).
These 50 patients are 1:1 randomly assigned to 2 groups including control group and intervention group. Control group (n=25) applied CGM without structured education and after 3 months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected. As a sequential extension clinical trial, those 25 patients in control group are provided structured education, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected.
In Intervention group (n=25), structured education program is provided for each patient from the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CGM apply followed by structured education of CGM
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Structured Education for new glucose management devicesWithout structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply |
| Intervention | Active comparator | Behavioral: Structured Education for new glucose management devicesprovide structured education when applying CGM for 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 18 years old - under 70 years old patients with Type 1 diabetes
- Those who plan to use CGM G5
- Patients who consented to use CGM G5 in conjunction with Clarity
- Those who are using multiple insulin injections or insulin pumps for at least 3 months
- Those whose fasting c-peptide <0.6 ng / dL, or stimulated c-peptide <1.8 ng / dL
Key exclusion criteria (7 listed)
- Those with a history of severe hypoglycemia and acute ketoacidosis within the last 3 months
- Patients with chronic renal function greater than or equal to stage 4 (estimated glomerular filtration rate [assessed by MDRD (modification of diet in renal disease] <30 )
- Patients with acute myocardial infarction, unstable angina, coronary artery disease or stroke within the last 3 months
- Patients with adrenal insufficiency, pituitary dysfunction, medically uncontrolled hyperthyroidism or hypothyroidism
- Those taking medications that can affect the glucose metabolism (eg, corticosteroids, immunostimulants, etc.)
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 |
|---|---|---|
| Structured Education for new glucose management devicesIndividualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus | Behavioural | Control, Intervention |
Primary outcome
Percentage of time in target range 70-180 mg/dL
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
13 secondary outcomes
Percentage of time in level 2 hypoglycemia (<54mg/dL)
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hyperglycemia (>180mg/dL)
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hyperglycemia (>250mg/dL)
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as coefficient of variance (CV)
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as standard deviation (SD)
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Mean glucose by continuous glucose monitoring system
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
HbA1C
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
glycated albumin
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Personalized education time for each patient
Time frame: baseline (intervention group) and 3months (for extension study in control group)
Frequency of hypoglycemia
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Adverse event
Time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL
Time frame: 6months (for extension study in control group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 35065101Yoo JH, Kim G, Lee HJ, Sim KH, Jin SM, Kim JH. Effect of structured individualized education on continuous glucose monitoring use in poorly controlled patients with type 1 diabetes: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Feb;184:109209. doi: 10.1016/j.diabres.2022.109209. Epub 2022 Jan 19.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Education for new glucose management devices in people with Type 1 Diabetes Mellitus, 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hyeon Kim, MD PhD (82-2-3410-3439, jaehyeonmd.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in target range 70-180 mg/dL (time frame: 3months (control and intervention groups) and 6months (for extension study in control group)). 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 NCT03794934, 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 25 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.