Diabetes MellitusNCT05149625
Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy
A study testing Dexcom G6 in people with Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to compare the efficacy and satisfaction of blood glucose management between continuous glucose monitoring versus traditional self blood glucose measurement in diabetic patients after pancreatectomy. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Dexcom G6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 19 years of age
- Preoperative diabetes history
- Patients who underwent subtotal or total pancreatectomy
- Patients who were diagnosed with diabetes mellitus in the evaluation of endocrine function test on the 7th day after pancreaticoduodenectomy, central pancreatectomy, or distal pancreatectomy
Who cannot join
- Patients who have used continuous blood glucose measurement device more than once before.
- Elderly patients who are not accustomed to using the smartphone applications
- Serious systemic diseases that can affect diabetes (chronic kidney disease, heart failure, decompensated liver cirrhosis, etc.)
- Steroid user during the study period
- Major medical or psychiatric condition that will affect response to treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Surgery, Seoul National University College of Medicine
Seoul, 110-744
Jin- Young Jang, M.D., PhD., 82-2-2072-2194, jangjy4@gmail.com
Wooil Kwon, M.D., PhD., 82-2-2072-2817, willdoc78@gmail.com
About this study
Official title: Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy : A Randomized Controlled Open Labeled Trial
This study aims to compare the efficacy and satisfaction of blood glucose management between continuous glucose monitoring versus traditional self blood glucose measurement in diabetic patients after pancreatectomy.
Read the detailed description
Patients will be enrolled after the 75g oral glucose tolerance test performed 7 days after pancreatectomy. Patients will be divided into two groups by randomization (continuous glucose measurement method vs. traditional self blood glucose measurement method), and 3months after surgery, HbA1c, hypoglycemic events, and satisfaction would be compared.
- Conditions
- Diabetes Mellitus
- Being tested
- Dexcom G6
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6Device
continuous glucose monitoring device
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 | Experimental | Not described Receives: Device: Dexcom G6 |
| Traditional self-blood glucose measurement | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
Measured: postoperative 3months
Secondary outcomes (3)
Hypoglycemic events
Measured: postoperative 3months
satisfaction survey
Measured: postoperative 3months
Fasting, postprandial plasma glucose
Measured: postoperative 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start27 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
- Investigators
- Jin-Young Jang, Dr, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149625
- Sponsor's protocol ID
- H-2109-138-1257
- Status last verified
- Apr 2023
- First submitted
- 26 Nov 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy : A Randomized Controlled Open Labeled Trial
- ClinicalTrials.gov ID
- NCT05149625
- Acronym / sponsor ID
- H-2109-138-1257
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2021 (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 aims to compare the efficacy and satisfaction of blood glucose management between continuous glucose monitoring versus traditional self blood glucose measurement in diabetic patients after pancreatectomy.
Detailed description
Patients will be enrolled after the 75g oral glucose tolerance test performed 7 days after pancreatectomy. Patients will be divided into two groups by randomization (continuous glucose measurement method vs. traditional self blood glucose measurement method), and 3months after surgery, HbA1c, hypoglycemic events, and satisfaction would be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexcom G6 | Experimental | Device: Dexcom G6 |
| Traditional self-blood glucose measurement | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 19 years of age
- Preoperative diabetes history
- Patients who underwent subtotal or total pancreatectomy
- Patients who were diagnosed with diabetes mellitus in the evaluation of endocrine function test on the 7th day after pancreaticoduodenectomy, central pancreatectomy, or distal pancreatectomy
Key exclusion criteria (5 listed)
- Patients who have used continuous blood glucose measurement device more than once before.
- Elderly patients who are not accustomed to using the smartphone applications
- Serious systemic diseases that can affect diabetes (chronic kidney disease, heart failure, decompensated liver cirrhosis, etc.)
- Steroid user during the study period
- Major medical or psychiatric condition that will affect response to treatment
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 |
|---|---|---|
| Dexcom G6continuous glucose monitoring device | Device | Dexcom G6 |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: postoperative 3months
3 secondary outcomes
Hypoglycemic events
Time frame: postoperative 3months
satisfaction survey
Time frame: postoperative 3months
Fasting, postprandial plasma glucose
Time frame: postoperative 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- 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.
Jin-Young Jang, Dr principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 in people with Diabetes Mellitus, run by Seoul National University Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 12 Apr 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Jang, Dr (+82-02-2072-2194, jangjy4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) (time frame: postoperative 3months). 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 12 Apr 2023.