Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China

NCT04129424 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-10-16

No results posted yet for this study

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 multiple insulin injections including better glycaemic control with lower daily insulin requirement, lower glycated haemoglobin (HbA1c) level and reduced risk of severe hypoglycaemia. The best mode of CSII is a kind of programmed and individualized insulin infusion mode. But at present, the applying of insulin pump is mainly during hospitalization period in China, which is not conformed with daily living scenarios of patients. The outpatient insulin pump treatment is much closer to the real living scenarios of patients. However, lack of management experience and widely accepted formative model of insulin pump applying in clinic restricted use of insulin pumps in clinical in China. The investigators aimed to explore a safe and effective management mode of insulin pump operating to enable a wide population to have access to daily use of CSII, and to maximize the rational use of limited medical resources.

Conditions

  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
  • Gestational Diabetes Mellitus
  • Pancreatogenic Diabetes Mellitus
  • Pregestational Diabetes Mellitus
  • Diabetes Patients in Perioperative Period

Interventions

DEVICE

Insulin pump (Microtech, Equil®)

Those patients of different types of diabetes mellitus were assigned to different groups, those groups were classified by the time to reach target blood glucose .

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129424 on ClinicalTrials.gov