Injection Ports vs Single-Use Needles for Insulin in Pregnancy: Effects on Adherence and Satisfaction
Diabetes management during pregnancy is crucial for both maternal and fetal health, requiring frequent blood glucose monitoring and insulin administration. Traditional methods of insulin injection involve up to 5 insulin injections per day. These methods, while effective, can be burdensome, and many patients desire to avoid frequent injections. Injection ports are small, single-use, prescription medical devices designed to simplify insulin or other subcutaneous medication delivery. They consist of a soft cannula that sits under the skin for up to 72 hours and a resealable septum through which multiple injections can be administered without repeated needle sticks. The I-port is an injection port that is FDA approved for use in the United States, but is rarely used in clinical practice, largely because it is not typically covered by insurance. Given the importance of management of diabetes throughout pregnancy, patient satisfaction with insulin delivery methods may play a significant role in treatment adherence and overall health outcomes. The use of injection ports has been shown to improve patient satisfaction in pregnant patients requiring heparin administration in pregnancy, as well as improve patient experiences for insulin administration in non-pregnant populations. However, there are no studies that have evaluated the use of injection ports for insulin administration in pregnancy. This study aims to assess patient satisfaction with the use of injection ports for insulin administration among pregnant patients with diabetes.
- Sex: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 50 Years
Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:
Inclusion Criteria
- Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen
Exlusion Criteria
- T1DM, primary language non-English or Spanish, use of an insulin pump
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Gestatiaonl Diabetes Mellitus, Pregnancy, Diabetes in Pregnancy, Insulin Dependent Diabetes Mellitus, InsulinIntervention/Treatment
Intervention/Treatment
- DEVICE : Injection Port for Insulin Administration
- DEVICE : Single-Use Insulin Needles
Sponsor
University of Texas at Austin
Principal Investigator(s)
- Lorie Harper, PRINCIPAL_INVESTIGATOR, University of Texas at Austin, Dell Medical School
Phase
- NA