Status:
UNKNOWN
Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Continuous subcutaneous insulin infusion (CSII), known as insulin pump therapy, has been widely used for diabetes patients in recent years. Many clinical studies have proved the priority of CSII to mu...
Detailed Description
In this study, the investigators plan to enroll patients of different types of diabetes, including type 1 diabetes mellitus, type 2 diabetes mellitus, gestational diabetes mellitus, perioperative diab...
Eligibility Criteria
Inclusion
- Patients in clinic of type 1 diabetes mellitus, type 2 diabetes mellitus, gestational/pregestational diabetes mellitus, perioperative diabetes mellitus and patients with diabetes mellitus after pancreatectomy, including those with poor blood glucose control using multiple subcutaneous insulin injections or those are willing to use insulin pump therapy;
- Age: 18-80 years old;
- Patients and family members understand the research program and are willing to participate in the study and sign written informed consent.
Exclusion
- allergic to dressings and subcutaneous transfusion tubes;
- allergic to insulin;
- Severe diabetic acute complications within 6 months(diabetic ketoacidosis, diabetic hyperglycemia and hyperosmolar state, diabetic lactic acidosis).
- Severe chronic complications of diabetes mellitus, such as peripheral vascular lesions leading to amputation or chronic foot ulcer, end-stage renal disease, etc. who researchers thought not suitable for this study.
- Two or more times of severe hypoglycemia occured in the past year (such as consciousness disturbance and coma caused by hypoglycemia), or severe unconscious hypoglycemia.
- Patients with severe impairment of cardiac function (NYHA grade III or above), liver function (alanine aminotransferase, aspartate aminotransferase or total bilirubin higher than the upper limit of normal value 2 times or more), renal function (serum creatinine higher than the upper limit of normal value) or circulation disorder;
- Patients with mental illness and self-care ability;
- Patients or their families could not understand the conditions and objectives of this study.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04129424
Start Date
December 1 2019
End Date
December 1 2020
Last Update
October 16 2019
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730