This study wants to find out if using an injection port to give insulin during pregnancy helps people take their insulin more regularly and feel better about their care.
When someone has diabetes during pregnancy, it's very important to keep their blood sugar levels in a healthy range. This usually means checking blood sugar often and giving insulin through shots. But giving many shots each day can be hard and uncomfortable.
An injection port is a small device placed on the skin that lets patients give insulin through the same spot without poking themselves each time. This may make taking insulin easier and less painful.
Feeling comfortable with how insulin is given may help people stick to their treatment plan and have better health during pregnancy. Injection ports have already helped other patients, including pregnant people who needed other medications, but they haven't been studied for insulin use during pregnancy. This study will look at how pregnant patients with diabetes feel about using injection ports for insulin.
Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen
T1DM, primary language non-English or Spanish, use of an insulin pump
Crossover
Injection Port for Insulin Administration
DeviceFor two weeks, participants will use an injection port device for all prescribed insulin doses during pregnancy. The port is inserted and replaced approximately every 3 days. Insulin is delivered through the port using standard syringes or insulin pens, eliminating the need for multiple daily needle sticks.
Single-Use Insulin Needles
DeviceFor two weeks, participants will use standard single-use disposable needles for all prescribed insulin doses during pregnancy. A new sterile needle will be used for each injection, consistent with routine clinical practice.
Compliance with insulin administration
Patients' compliance with their insulin administration during each arm will be assessed by determining the total number of insulin doses that were missed.
Patient satisfaction
Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey
Glucose control
In each arm, patients' overall glucose control will be assessed by determining their percent time in range, mean fasting glucose (mg/dL), and mean postprandial glucose (mg/dL).
Hypoglycemia episodes
Patients will be assessed on the frequency of hypoglycemia episodes in each arm
Adverse reactions
Patients will be assessed for adverse reactions with each regimen, including allergic reactions or infections
Device malfunctions
In each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience
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This trial is not recruiting at the moment. You can still explore other options:
