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NCT Number: NCT05149625

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

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location status: Recruiting

Location contact

Jin- Young Jang, M.D., PhD.

CONTACT

[email protected]

82-2-2072-2194

Jin- Young Jang, M.D., PhD.

PRINCIPAL_INVESTIGATOR

Wooil Kwon, M.D., PhD.

CONTACT

[email protected]

82-2-2072-2817

Wooil Kwon, M.D., PhD.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom G6

Device

continuous glucose monitoring device

Primary outcomes

  1. Hemoglobin A1c (HbA1c)

    Time frame: postoperative 3months

Secondary outcomes

  1. Hypoglycemic events

    Time frame: postoperative 3months

  2. satisfaction survey

    Time frame: postoperative 3months

  3. Fasting, postprandial plasma glucose

    Time frame: postoperative 3months

Study contacts

Contact information is provided by the study sponsor or research team.

Jin-Young Jang, Dr

CONTACT

[email protected]

+82-02-2072-2194

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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