Clinical trial NCT05001815: CSII Versus MDI in Pregnant Women With Type 2 Diabetes
Official title: Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injection in Pregnant Women With Type 2 Diabetes: A Single-center Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Pregnancy in Diabetic
Keywords: type 2 diabetes
pregnancy
continuous subcutaneous insulin infusion
multiple daily injection
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time in range (TIR) at 24 weeks of gestation
timeFrame: 24 weeks of gestation
measure: Time in range (TIR) at 28 weeks of gestation
timeFrame: 28 weeks of gestation
measure: Time in range (TIR) at 34 weeks of gestation
timeFrame: 34 weeks of gestation
Secondary outcomes:
measure: Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin
timeFrame: 24, 28, 34 weeks of gestation and 6 weeks of postpartum
measure: TIR calculated by patients' SMBG data
timeFrame: At 4 weeks after randomization, and at 24, 28, 34 and 38 weeks of gestation
measure: TAR and TBR
timeFrame: At 24, 28 and 34 weeks of gestation
measure: Blood glucose fluctuation index
timeFrame: At 24, 28 and 34 weeks of gestation
measure: The AUC of blood glucose within 24 hours before delivery
timeFrame: Within 24 hours before delivery
measure: Hypoglycemic events
timeFrame: From randomization, up to 42 weeks of gestation
measure: Insulin requirements
timeFrame: 4 weeks after randomization, 24, 28, 34 weeks of gestation and 6 weeks of postpartum.
measure: Hypertension during pregnancy
timeFrame: From randomization, up to 42 weeks of gestation
measure: Caesarean sections at delivery
timeFrame: At delivery
measure: Gestational weight gain
timeFrame: 24, 28, 34 weeks of gestation and 6 weeks of postpartum
measure: Maternal hospital stay
timeFrame: From admission to discharge from hospital due to delivery
measure: Infant birthweight
timeFrame: At delivery
measure: Pregnancy loss
timeFrame: From randomization, up to 28 days after delivery
measure: Infant Outcomes (Gestational week of delivery)
timeFrame: At birth
measure: Infant Outcomes (Apgar score)
timeFrame: At birth
measure: Infant Outcomes (Up to first 7 days of infants' life)
timeFrame: Up to first 7 days of infants' life
measure: Infant Outcomes (Up to f first 7 days of life)
timeFrame: Up to first 7 days of infants' life
measure: The composite endpoint of infants
timeFrame: Up to first 7 days of infants' life
measure: Questionnaires (WHO-5 physical and mental health index)
timeFrame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
measure: Questionnaires (Self-manage behavior scale)
timeFrame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
measure: Questionnaires (Self-efficacy scale for diabetes mellitus)
timeFrame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
measure: Questionnaires (Self-rated Anxiety Scale, SAS)
timeFrame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
measure: Questionnaires (Self-rated Depression Scale, SDS)
timeFrame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: