Type 1 DiabetesNCT04684030
The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
A study testing Continuous glucose monitoring system(CGMS) and Self-monitoring of blood glucose (conventional fingerpricking method) in people with Type 1 Diabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Continuous glucose monitoring system(CGMS) and Self-monitoring of blood glucose (conventional fingerpricking method)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2020to Aug 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ages >= 20 years
- Patients diagnosed with type 1 diabetes.
- Patients with glycated hemoglobin (HbA1c) > 8.0% within 6 months before screening
- Patients who agree to perform self blood glucose monitoring responsibly during the study period
- Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment
Who cannot join
- Patients diagnosed with type 2 diabetes.
- Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
- Patients who cannot use the device properly such as an illiterate person or foreigners
- Patients incapable of making decisions based on their own judgement and will
- A person who may not participate in the study according to investigator's judgement
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine
Seoul
EunSeok Kang, Ph.D, +82-2-2228-1968, EDGO@yuhs.ac
About this study
This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.
- Conditions
- Type 1 Diabetes
- Being tested
- Continuous glucose monitoring system(CGMS), Self-monitoring of blood glucose (conventional fingerpricking method)
- 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.
Continuous glucose monitoring system(CGMS)Device
Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in CGMS group will given education on how to use the device and check the result using the smart phone. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total numbers of scans conducted during the study period.
Self-monitoring of blood glucose (conventional fingerpricking method)Device
Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in SMBG group will check their blood glucose by finger pricking method and record the data in a notebook to share the data in their outpatient clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| CGMS group | Experimental | Using continuous glucose monitoring system(CGMS) group Receives: Device: Continuous glucose monitoring system(CGMS) |
| SMBG group | Active comparator | Self-monitoring of blood glucose group (conventional fingerpricking method) Receives: Device: Self-monitoring of blood glucose (conventional fingerpricking method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of glycated hemoglobin (HbA1c) level
The HbA1c levels in this study will analyzed twice during the study, once at the baseline and after the CGMS testing was initiated. The improvement of HbA1c level in CGMS group will be estimated and compare it with the change in HbA1c level in the SMBG group.
Measured: 12 weeks after applying continuous glucose monitoring system
Secondary outcomes (1)
The number of participants with improved clinical glycometabolic parameters
Clinical glycometabolic parameters (HbA1c, glycated albumin, glycemic variability, hypoglycemia, calculated insulin dose, patient's self confidence in diabetes self-care, Quality of life) and anthropometric parameters (Blood pressure, Body weight, BMI etc)
Measured: 12 weeks after applying continuous glucose monitoring system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start28 Aug 2020
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EunSeok Kang, Ph.D, Principal investigator, Severance Hospital Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684030
- Sponsor's protocol ID
- 4-2020-0831
- Status last verified
- May 2021
- First submitted
- 20 Dec 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04684030
- Acronym / sponsor ID
- 4-2020-0831
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 24 Dec 2020 (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 study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group.
| Arm | Type | Receives |
|---|---|---|
| CGMS group | Experimental | Device: Continuous glucose monitoring system(CGMS)Using continuous glucose monitoring system(CGMS) group |
| SMBG group | Active comparator | Device: Self-monitoring of blood glucose (conventional fingerpricking method)Self-monitoring of blood glucose group (conventional fingerpricking method) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients ages >= 20 years
- Patients diagnosed with type 1 diabetes.
- Patients with glycated hemoglobin (HbA1c) > 8.0% within 6 months before screening
- Patients who agree to perform self blood glucose monitoring responsibly during the study period
- Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment
Key exclusion criteria (5 listed)
- Patients diagnosed with type 2 diabetes.
- Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
- Patients who cannot use the device properly such as an illiterate person or foreigners
- Patients incapable of making decisions based on their own judgement and will
- A person who may not participate in the study according to investigator's judgement
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 |
|---|---|---|
| Continuous glucose monitoring system(CGMS)Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in CGMS group will given education on how to use the device and check the result using the smart phone. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total numbers of scans conducted during the study period. | Device | CGMS group |
| Self-monitoring of blood glucose (conventional fingerpricking method)Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in SMBG group will check their blood glucose by finger pricking method and record the data in a notebook to share the data in their outpatient clinic visit. | Device | SMBG group |
Primary outcome
The change of glycated hemoglobin (HbA1c) level
Time frame: 12 weeks after applying continuous glucose monitoring system
The HbA1c levels in this study will analyzed twice during the study, once at the baseline and after the CGMS testing was initiated. The improvement of HbA1c level in CGMS group will be estimated and compare it with the change in HbA1c level in the SMBG group.
1 secondary outcome
The number of participants with improved clinical glycometabolic parameters
Time frame: 12 weeks after applying continuous glucose monitoring system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- 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.
EunSeok Kang, Ph.D principal investigator
Severance Hospital Diabetes 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 Continuous glucose monitoring system(CGMS) and Self-monitoring of blood glucose (conventional fingerpricking method) in people with Type 1 Diabetes, run by Yonsei University 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 5 inclusion and 5 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 6 May 2021. 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. 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 EunSeok Kang, Ph.D (+82-2-2228-1968, EDGO@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of glycated hemoglobin (HbA1c) level (time frame: 12 weeks after applying continuous glucose monitoring system). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.