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

NCT ID: NCT05149625

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-27

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dexcom G6

Group Type EXPERIMENTAL

Dexcom G6

Intervention Type DEVICE

continuous glucose monitoring device

Traditional self-blood glucose measurement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexcom G6

continuous glucose monitoring device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Jang

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Young Jang, Dr

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Department of Surgery, Seoul National University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin-Young Jang, Dr

Role: CONTACT

+82-02-2072-2194

Facility Contacts

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

Role: primary

82-2-2072-2194

Wooil Kwon, M.D., PhD.

Role: backup

82-2-2072-2817

Other Identifiers

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H-2109-138-1257

Identifier Type: -

Identifier Source: org_study_id

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