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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The CSII device used in this study has access to mobile phone, however, without CGM enhanced function
Patients with indication will receive MDI treatment with at least one basal insulin injection plus 2 to 3 prandial insulin injection.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Time in range (TIR) at 24 weeks of gestation
Glycemic control as measured by time in range (TIR) acquired from retrospective continuous glucose monitoring devices (r-CGM) at 24 weeks of gestation among women with type 2 diabetes mellitus.
Time frame: 24 weeks of gestation
Time in range (TIR) at 28 weeks of gestation
Glycemic control as measured by time in range (TIR) acquired from retrospective continuous glucose monitoring devices (r-CGM) at 28 weeks of gestation among women with type 2 diabetes mellitus.
Time frame: 28 weeks of gestation
Time in range (TIR) at 34 weeks of gestation
Glycemic control as measured by time in range (TIR) acquired from retrospective continuous glucose monitoring devices (r-CGM) at 34 weeks of gestation among women with type 2 diabetes mellitus.
Time frame: 34 weeks of gestation
Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin
Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin in meta-late phase of pregnancy.
Time frame: 24, 28, 34 weeks of gestation and 6 weeks of postpartum
TIR calculated by patients' SMBG data
TIR calculated by patients' SMBG data at 4 weeks after randomization, and at 24, 28, 34 and 38 weeks of gestation.
Time frame: At 4 weeks after randomization, and at 24, 28, 34 and 38 weeks of gestation
TAR and TBR
Time above range (TAR) and time below range (TBR) calculated by CGM data at 24, 28 and 34 weeks of gestation.
Time frame: At 24, 28 and 34 weeks of gestation
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Blood glucose fluctuation index
Mean amplitude of glucose excursion (MAGE), coefficient of variation (CV) and standard deviation (SD) calculated by CGM data recorded at 24, 28 and 34 weeks of gestation.
Time frame: At 24, 28 and 34 weeks of gestation
The AUC of blood glucose within 24 hours before delivery
The area under curve (AUC) of peripheral blood glucose within 24 hours before delivery: (a) \>7.8 mmol/l or 140 mg/dl (b)\>6.7 mmol/l or 120 mg/dl (c) \<3.5 mmol/L or \<63 mg/dl (d) \<2.8 mmol/L or \<50 mg/dl.
Time frame: Within 24 hours before delivery
Hypoglycemic events
(a)Episodes of severe hypoglycemia requiring assistance. (b)Episodes of mild-moderate episodes of hypoglycemia \< 3.5mmol/L (mild) and \< 2.8 mmol/L (moderate) from patients' SMBG data or from CGM data defined as AUC \<3.5 mmol/L or AUC less than or equal to 2.8 mmol/L for 20 minutes duration. (c) Nocturnal hypoglycemia defined as glucose \<3.5 (mild) and \<2.8 (moderate) by SMBG or CGM between the hours of 23.00-07.00.
Time frame: From randomization, up to 42 weeks of gestation
Insulin requirements
The total daily insulin dosage at randomization, 4 weeks after randomization, and 24, 28, 34 weeks of gestation as well as 6 weeks of postpartum.
Time frame: 4 weeks after randomization, 24, 28, 34 weeks of gestation and 6 weeks of postpartum.
Hypertension during pregnancy
Hypertension during pregnancy (up to 42 weeks of gestation): Incidence of worsening of chronic hypertension, gestational hypertension, preeclampsia.
Time frame: From randomization, up to 42 weeks of gestation
Caesarean sections at delivery
Incidence of caesarean section (primary and total)
Time frame: At delivery
Gestational weight gain
Gestational weight gain: Absolute and relative weight gain at 24, 28, 34 weeks of gestation and 6 weeks of postpartum comparing to baseline (4-8 weeks of gestation at the time of enrollment)
Time frame: 24, 28, 34 weeks of gestation and 6 weeks of postpartum
Maternal hospital stay
Length of hospital stay including admission for delivery and for other obstetric situations during pregnancy.
Time frame: From admission to discharge from hospital due to delivery
Infant birthweight
Infant birthweight (at birth): Infant birthweight\>90th centile using customized growth curves; infant birthweight\<10th centile using customized growth curves; infant birthweight≥4000g or ≤2500g.
Time frame: At delivery
Pregnancy loss
Including miscarriage, stillbirth and neonatal death (≤28 days of life).
Time frame: From randomization, up to 28 days after delivery
Infant Outcomes (Gestational week of delivery)
Infant Outcomes (at birth): The incidence of preterm delivery (\<37 weeks and early preterm \<34 weeks) and post-term delivery (\>42 weeks).
Time frame: At birth
Infant Outcomes (Apgar score)
Infant Outcomes (at birth): Apgar score
Time frame: At birth
Infant Outcomes (Up to first 7 days of infants' life)
The incidence of birth injury, shoulder dystocia, neonatal hypoglycemia with intravenous dextrose.
Time frame: Up to first 7 days of infants' life
Infant Outcomes (Up to f first 7 days of life)
Incidence of hyperbilirubinemia, respiratory Distress Syndrome (RDS), NICU admission \> 24 hours.
Time frame: Up to first 7 days of infants' life
The composite endpoint of infants
The combined adverse outcomes of infants including miscarriage, stillbirth and neonatal death; Neonatal birth injury, shoulder dystocia, neonatal hypoglycemia (requiring intravenous glucose infusion), neonatal jaundice, neonatal respiratory distress syndrome (RDS) and more than 24 hours of treatment in NICU.
Time frame: Up to first 7 days of infants' life
Questionnaires (WHO-5 physical and mental health index)
The score of World health organization (WHO)-5 physical and mental health index acquired from patients. The WHO-5 scale (1998 version) was used to measure the patient's quality of life. The scale contains 5 items which initial points is 0-25. The initial points are multiplied by 4 to obtain the percentage points, ranging from 0 to 100，which are used to monitor possible changes in physical and mental health. 0 represents the worst possible quality of life, 100 represents the best possible quality of life, and a difference of 10% indicates significant changes.
Time frame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
Questionnaires (Self-manage behavior scale)
The score of Self-manage behavior scale acquired from patients. Diabetes self-care behaviors includes a range of activities (e.g., eating diabetic food, exercising, glucose monitoring and taking medicine), which were evaluated by the Summary of Diabetes Self-Care Activities (SDSCA). SDSCA, compiled by Toobert in 2000, is an 8-likert scale containing 11 items belongs to 6 dimensions, could estimate general diet, special diet, physical activity, glucose monitoring, foot care and medicine compliance of patients with T2DM. The total scores range from 0 to 77, higher score means better diabetes self- care behaviors.
Time frame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
Questionnaires (Self-efficacy scale for diabetes mellitus)
The score of self-efficacy scale for diabetes mellitus acquired from patients. Self-Efficacy for Diabetes (SED), a 5-Likert scale including 9 items, is used to measure patients' self-efficacy. The average score is 1-5 points, and the higher the average score, the higher the self-efficacy level of participants. The effectiveness and internal consistency of the Chinese version of SED are reliable, and the load factors of each factor are between 0.579-0.922.
Time frame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
Questionnaires (Self-rated Anxiety Scale, SAS)
The score of Self-rated Anxiety Scale (SAS) acquired from patients. Self-Rating Anxiety Scale (SAS) is used to measure the degree of anxiety in patients. There are 20 items in total. The scores are divided into 4 levels, including 5 (items 5, 9, 13, 17, 19) reverse scoring items and 15 positive scoring items. Add the scores of the 20 items to get the rough score, then multiply it by 1.25 and take the integer part to get the standard score. The higher the standard score, the more serious the degree of anxiety.
Time frame: At randomization, 34 weeks of gestation and 6 weeks of postpartum
Questionnaires (Self-rated Depression Scale, SDS)
The score of Self-rated Depression Scale (SDS) acquired from patients. The Self-Rating Depression Scale (SDS) is used to measure the degree of depression in patients. There are 20 items in total, including 10 (items 2, 5, 6, 11, 12, 14, 16, 17, 18, and 20) reverse scoring items, and 15 positive scoring items. The depression severity index can be calculated by the cumulative score of each item divided by 80, which could reflect the degree of depression. The index range is 0.25-1.0, and the higher the index, the more severe the degree of depression.
Time frame: At randomization, 34 weeks of gestation and 6 weeks of postpartum