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

April 10, 2023 updated by: Jin-Young Jang, Seoul National University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Department of Surgery, Seoul National University College of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin- Young Jang, M.D., PhD.
        • Sub-Investigator:
          • Wooil Kwon, M.D., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexcom G6
Device: Dexcom G6
continuous glucose monitoring device
No Intervention: Traditional self-blood glucose measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: postoperative 3months
postoperative 3months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemic events
Time Frame: postoperative 3months
postoperative 3months
satisfaction survey
Time Frame: postoperative 3months
postoperative 3months
Fasting, postprandial plasma glucose
Time Frame: postoperative 3months
postoperative 3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Young Jang, Dr, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2022

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

November 26, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • H-2109-138-1257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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