Application of Needle-free Injection of Insulin in Patients With Gestational Diabetes Mellitus
NCT ID: NCT05394727
Last Updated: 2023-03-29
Study Results
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-04-01
2023-06-30
Brief Summary
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Detailed Description
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Test group: "Needle-free injection device, Then traditional insulin pen" Patients first received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks.
Control group: "Traditional insulin pen , Then Needle-free injection device" Patients first received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Control group: use traditional insulin pen injection and replace it with needle-free syringe after 2 weeks.
OTHER
NONE
Study Groups
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Needle-free injection first group
Use needle-free syringe for insulin injection in patients for 2 weeks, then replace it with conventional insulin pen injection for another 2 weeks.
Needle-free injection device, Then traditional insulin pen
Patients first received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks.
Traditional insulin pen first group
Use conventional insulin pen for insulin injection in patients for 2 weeks, then replace it with needle-free syringe injection for another 2 weeks.
Traditional insulin pen , Then Needle-free injection device
Patients first received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks.
Interventions
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Needle-free injection device, Then traditional insulin pen
Patients first received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks.
Traditional insulin pen , Then Needle-free injection device
Patients first received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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yaoming Xue
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital, southern medical university
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2019-257
Identifier Type: -
Identifier Source: org_study_id
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