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
1 other identifier
interventional
172
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Nov 2022
Longer than P75 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedStudy Start
First participant enrolled
November 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 12, 2023
April 1, 2023
4.1 years
November 26, 2021
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c)
postoperative 3months
Secondary Outcomes (3)
Hypoglycemic events
postoperative 3months
satisfaction survey
postoperative 3months
Fasting, postprandial plasma glucose
postoperative 3months
Study Arms (2)
Dexcom G6
EXPERIMENTALTraditional self-blood glucose measurement
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Seoul National University College of Medicine
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Young Jang, Dr
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 26, 2021
First Posted
December 8, 2021
Study Start
November 27, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share