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NCT05149625 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05149625
Other study ID # H-2109-138-1257
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 27, 2022
Est. completion date December 31, 2026

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact Jin-Young Jang, Dr
Phone +82-02-2072-2194
Email jangjy4@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 172
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dexcom G6
continuous glucose monitoring device

Locations
Country Name City State
Korea, Republic of Department of Surgery, Seoul National University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c (HbA1c) postoperative 3months
Secondary Hypoglycemic events postoperative 3months
Secondary satisfaction survey postoperative 3months
Secondary Fasting, postprandial plasma glucose postoperative 3months
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