Status:
UNKNOWN
Application of Needle-free Injection of Insulin in Patients With Gestational Diabetes Mellitus
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Injection
Blood Glucose, High
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is about the application of needle-free injection device in GDM patients in order to observe the variation of blood glucose and patients' experience compared to the traditional insulin pen ...
Detailed Description
This study is a prospective, randomized, unblinded,crossover and controlled clinical trail. The first patient was enrolled on November 1, 2019. The follow-up visit of all enrolled patients in our cent...
Eligibility Criteria
Inclusion
- Patients'diagnostic criteria of gestational diabetes mellitus(GDM) is according to the Guidelines for the prevention and control of type 2 diabetes in China (2017 Edition).
- fasting glucose or 2h post prandial glucose was abnormal after 3days' dietary control (fasting glucose ≥ 6.1 mmol/L, or 2h post prandial glucose ≥7.8 mmol/L).
- Aged≥20 years, Han, singleton pregnancy.
- Patients who gave informed consent voluntarily participated in the study, and had regular perinatal examination at our hospital and intended to deliver at our hospital.
Exclusion
- Patients with multiple pregnancy or undergoing assisted reproductive technology.
- Patients with polycystic ovary syndrome in preconception.
- Patients with other endocrine metabolic disorders such as gestational hypertension and hyperthyroidism.
- Patients with severe anemia and hypoproteinemia, abnormal liver and kidney function, severe heart failure, respiratory failure and other systemic diseases.
- Patients on long-term medications that affect glucose metabolism.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05394727
Start Date
April 1 2021
End Date
June 30 2023
Last Update
March 29 2023
Active Locations (1)
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1
Nanfang Hospital, southern medical university
Guangzhou, Guangdong, China, 510515