CSII Versus MDI in Pregnant Women With Type 2 Diabetes

Peking University

Status: Unknown

Conditions: Pregnancy in Diabetic; Type 2 Diabetes

Treatments: Device: Multiple daily insulin injection (MDI); Device: Continuous subcutaneous insulin infusion (CSII)

Study type: Interventional

Funder types: Other

Identifiers

NCT05001815

2021NFM001

Details and patient eligibility

About

The primary objective of the study is to determine if continuous subcutaneous insulin infusion (CSII) can improve glycemic control in women with type 2 diabetes (T2D) who are pregnant.

Full description

In women with diabetes, hyperglycemia is associated with increased rates of maternal and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, deterioration of proteinuria and caesarean sections. Infants of mothers with diabetes have increased rates of congenital anomalies, premature delivery, macrosomia, stillbirth and NICU admissions, as well as increased risks of shoulder dystocia, birth injury, hypoglycemia, hyperbilirubinemia, respiratory distress syndrome, asphyxia and death in the neonatal period. Several studies have shown that pregnancy outcomes can be improved along with better glycemic control. Theoretically CSII could achieve better glycemic control due to its flexibility in adjusting both basal rate and bolus insulin infusion. Several randomized controlled studies have compared the ability of CSII with multiple daily injection (MDI) in glycemic control and improvement of pregnancy outcomes in patients with type 1 diabetes (T1D). However, there is a lack of similar studies in women with T2D. We hypothesize that CSII will assist women with T2D achieve better glycemic control during pregnancy compared to MDI users.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 18 to 40 years old
2. Patients with confirmed history of T2D or patients who are newly diagnosed with T2D by oral glucose tolerance test (OGTT) during pregnancy (diagnostic criteria refer to ADA 2020 guideline for T2D).
3. Women with singleton pregnancy at 4 to 20 weeks of gestation, whose blood glucose fails to achieved glucose target after adequate lifestyle intervention with or without the prescription of basal insulin (i.e. fasting blood glucose above 5.3 mmol/L, or one hour postprandial blood glucose above 7.8 mmol/L, or two hour postprandial blood glucose above 6.7 mmol/L), and need to start intensive insulin therapy (MDI or insulin pump) according to the evaluation of endocrinologists.
4. Patients who are willing be followed up by the Third Hospital of Peking University in the whole process of pregnancy until 6 weeks of postpartum, and promise that they will provide the results of relative prenatal examinations and perinatal medical records if they are transferred to another hospital for special reasons.
5. Patients who can pass the compliance test and agree to conduct self-monitoring of blood glucose (SMBG) at least 7 times a day during pregnancy.
6. Patients who volunteer to participate the trial and agree to sign informed consent.

Exclusion criteria

1. Patients with T1D, special type of diabetes and gestational diabetes.
2. Patients who have received intensive insulin therapy (MDI or insulin pump) or premixed fixed doses of insulin before enrollment in this trial.
3. Patients who refuse to use insulin pump or CGM devices.
4. Patients who are not recommended by obstetrician to continue their pregnancy due to comorbidity and high risk of pregnancy. The comorbidities include but not limited to the following diseases: proliferative retinopathy, chronic kidney disease (eGFR less than 60 ml /min/1.73 with or without heavy proteinuria), known coronary heart disease and cerebrovascular disease, autoimmune disease, other diseases requiring exogenous glucocorticoid or immunosuppressive therapy.
5. Patients who received inpatient psychiatric treatment within 6 months before enrollment or still using psychiatric drugs.
6. Participated in other intervention studies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Continuous subcutaneous insulin infusion (CSII)

Experimental group

Description:

Patients with indications will receive continuous subcutaneous insulin infusion (CSII) treatment achieved by patch insulin pump devices.

Treatment:

Device: Continuous subcutaneous insulin infusion (CSII)

Multiple daily insulin injection (MDI)

Active Comparator group

Description:

Patients with indications will receive traditional multiple daily insulin injection (MDI) treatment.

Treatment:

Device: Multiple daily insulin injection (MDI)