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Assessment of the Efficiency and Safety for Using FreeStyle Libre H to Monitor Perioperative Blood Glucose Level in Patients Receiving Pancreatic Surgery

Assessment of the Efficiency and Safety for Using FreeStyle Libre H to Monitor Perioperative Blood Glucose Level in Patients Receiving Pancreatic Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030177
Enrollment
Unknown
Registered
2020-02-24
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative blood glucose metabolism

Interventions

Gold Standard:simultaneous POCT papillary blood glucose
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Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are admitted in to the department of pancreatic surgery in Huashan Hospital, and are planned to received selective or confine pancreatic surgery in which there will be a loss of normal pancreas volume. Patients should have no contraindications of planned surgery; 2. Patients aged 18 to 75 years male or female; 3. Patients should have no previous history of any types of diabetes mellitus (except for gestational diabetes mellitus), and should currently not have any medicine for controlling blood glucose; 4. Patients should fully understand the purpose of the study and be willing to participate in this study. All patients should signed the informed consent file before being enrolled in.

Exclusion criteria

Exclusion criteria: 1. Patients who have a local lesion (infection, bruise, etc.) of the skin or subcutaneous tissue at the upper part of their arm, which is not suitable for implanting the FL-FGM sensor; 2. Patients who have a history of anaphylactic reaction to the implanted device; 3. Preoperative lab results showed patients' fasting blood glucose >6.0mmol/L or HbA1c >6.5%; 4. Patients who do not have a complete self-care ability, or are unconsciousness, or cannot cooperative with routine POCT blood glucose metabolism; 5. Patients who are suspected for insulinoma, glucagonoma, ectopic ACTH syndrome or other diseases might have an influence on normal glucose metabolism; 6. Patients who have a previous history of pancreatic surgery or other surgeries which need cardiac bypass or extracorporeal circulation; 7. Patients who are currently having anti-platelet or anti-coagulation drugs (aspirin, warfarin, clopidogrel, etc.), and haven't stop taking the medicine for 2 weeks; 8. Patients who need long term use of glucocorticoids or immunosuppresive drugs; 9. Patients who have moderate to severe comorbidities, or preoperative studies find following results: 9.1 Cardiac function NYHA III-IV, or have a history of acute myocardial infarction in past 6 month. 9.2 Patients who have a history of CODP or asthma, and need long term therapy with oral or inhaled medicine; 9.3 Hepatic function Child-Pugh B-C, or ALT, AST higher than 3 times of the normal upper limit, or TBIL >=100umol/L; 9.4 CKD Stage 4-5, or serum creatinine higher than the normal upper limit. 9.5 Coagulation abnormalities. PT, APTT higher than 1.5 times of the normal upper limit, or INR higher than the normal upper limit, or platelet count =III; 9.9 History stroke in past 6 months; 9.10 Patients comorbid with infectious which have not been controlled yet; 9.11 Patients comorbid with psychological diseases; 10. Patients who have a history of scar constitution; 11. Patients who are pregnant or are in lactation; 12. Patients who have participated in another clinical trail for other drugs or medical equipment; 13. Other circumstance that researchers considering not suitable for the study.

Design outcomes

Primary

MeasureTime frame
The accuracy of FL-FGM;

Secondary

MeasureTime frame
The safety of FL-FGM;The pattern of perioperative blood glucose metabolism;

Countries

China

Contacts

Public ContactJi Li

Huashan Hospital, Fudan University

jili@huashan.org.cn+86 13816418978

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026