Back to resultsCSII Versus MDI in Pregnant Women With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Pregnancy in Diabetic
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous subcutaneous insulin infusion (CSII)
Multiple daily insulin injection (MDI)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, pregnancy, continuous subcutaneous insulin infusion, multiple daily injection
Eligibility Criteria
Inclusion Criteria:
- Women aged 18 to 40 years old
- 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).
- 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.
- 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.
- 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.
- Patients who volunteer to participate the trial and agree to sign informed consent.
Exclusion Criteria:
- Patients with T1D, special type of diabetes and gestational diabetes.
- Patients who have received intensive insulin therapy (MDI or insulin pump) or premixed fixed doses of insulin before enrollment in this trial.
- Patients who refuse to use insulin pump or CGM devices.
- 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.
- Patients who received inpatient psychiatric treatment within 6 months before enrollment or still using psychiatric drugs.
- Participated in other intervention studies.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuous subcutaneous insulin infusion (CSII)
Multiple daily insulin injection (MDI)
Arm Description
Patients with indications will receive continuous subcutaneous insulin infusion (CSII) treatment achieved by patch insulin pump devices.
Patients with indications will receive traditional multiple daily insulin injection (MDI) treatment.
Outcomes
Primary Outcome Measures
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 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 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.
Secondary Outcome Measures
Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin
Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin in meta-late phase of pregnancy.
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.
TAR and TBR
Time above range (TAR) and time below range (TBR) calculated by CGM data at 24, 28 and 34 weeks of gestation.
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.
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.
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.
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.
Hypertension during pregnancy
Hypertension during pregnancy (up to 42 weeks of gestation): Incidence of worsening of chronic hypertension, gestational hypertension, preeclampsia.
Caesarean sections at delivery
Incidence of caesarean section (primary and total)
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)
Maternal hospital stay
Length of hospital stay including admission for delivery and for other obstetric situations during pregnancy.
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.
Pregnancy loss
Including miscarriage, stillbirth and neonatal death (≤28 days of life).
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).
Infant Outcomes (Apgar score)
Infant Outcomes (at birth): Apgar score
Infant Outcomes (Up to first 7 days of infants' life)
The incidence of birth injury, shoulder dystocia, neonatal hypoglycemia with intravenous dextrose.
Infant Outcomes (Up to f first 7 days of life)
Incidence of hyperbilirubinemia, respiratory Distress Syndrome (RDS), NICU admission > 24 hours.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05001815
First Posted
July 26, 2021
Last Updated
November 28, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05001815
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2021 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Pregnancy in Diabetic
Keywords
type 2 diabetes, pregnancy, continuous subcutaneous insulin infusion, multiple daily injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous subcutaneous insulin infusion (CSII)
Arm Type
Experimental
Arm Description
Patients with indications will receive continuous subcutaneous insulin infusion (CSII) treatment achieved by patch insulin pump devices.
Arm Title
Multiple daily insulin injection (MDI)
Arm Type
Active Comparator
Arm Description
Patients with indications will receive traditional multiple daily insulin injection (MDI) treatment.
Intervention Type
Device
Intervention Name(s)
Continuous subcutaneous insulin infusion (CSII)
Intervention Description
The CSII device used in this study has access to mobile phone, however, without CGM enhanced function
Intervention Type
Device
Intervention Name(s)
Multiple daily insulin injection (MDI)
Intervention Description
Patients with indication will receive MDI treatment with at least one basal insulin injection plus 2 to 3 prandial insulin injection.
Primary Outcome Measure Information:
Title
Time in range (TIR) at 24 weeks of gestation
Description
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
Title
Time in range (TIR) at 28 weeks of gestation
Description
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
Title
Time in range (TIR) at 34 weeks of gestation
Description
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
Secondary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin
Description
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
Title
TIR calculated by patients' SMBG data
Description
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
Title
TAR and TBR
Description
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
Title
Blood glucose fluctuation index
Description
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
Title
The AUC of blood glucose within 24 hours before delivery
Description
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
Title
Hypoglycemic events
Description
(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
Title
Insulin requirements
Description
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.
Title
Hypertension during pregnancy
Description
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
Title
Caesarean sections at delivery
Description
Incidence of caesarean section (primary and total)
Time Frame
At delivery
Title
Gestational weight gain
Description
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
Title
Maternal hospital stay
Description
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
Title
Infant birthweight
Description
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
Title
Pregnancy loss
Description
Including miscarriage, stillbirth and neonatal death (≤28 days of life).
Time Frame
From randomization, up to 28 days after delivery
Title
Infant Outcomes (Gestational week of delivery)
Description
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
Title
Infant Outcomes (Apgar score)
Description
Infant Outcomes (at birth): Apgar score
Time Frame
At birth
Title
Infant Outcomes (Up to first 7 days of infants' life)
Description
The incidence of birth injury, shoulder dystocia, neonatal hypoglycemia with intravenous dextrose.
Time Frame
Up to first 7 days of infants' life
Title
Infant Outcomes (Up to f first 7 days of life)
Description
Incidence of hyperbilirubinemia, respiratory Distress Syndrome (RDS), NICU admission > 24 hours.
Time Frame
Up to first 7 days of infants' life
Title
The composite endpoint of infants
Description
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
Title
Questionnaires (WHO-5 physical and mental health index)
Description
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
Title
Questionnaires (Self-manage behavior scale)
Description
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
Title
Questionnaires (Self-efficacy scale for diabetes mellitus)
Description
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
Title
Questionnaires (Self-rated Anxiety Scale, SAS)
Description
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
Title
Questionnaires (Self-rated Depression Scale, SDS)
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 18 to 40 years old
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).
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.
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.
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.
Patients who volunteer to participate the trial and agree to sign informed consent.
Exclusion Criteria:
Patients with T1D, special type of diabetes and gestational diabetes.
Patients who have received intensive insulin therapy (MDI or insulin pump) or premixed fixed doses of insulin before enrollment in this trial.
Patients who refuse to use insulin pump or CGM devices.
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.
Patients who received inpatient psychiatric treatment within 6 months before enrollment or still using psychiatric drugs.
Participated in other intervention studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haining Wang, MD and Ph.D
Phone
+86-18211087263
Email
hainingmail@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Lu, MD
Phone
+86-01082265025
Email
luransurf@126.com
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Haining, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can contact the research group for IPD only for academic research, after the ethics committee re-evaluation and determination that the data transmission did not cause privacy disclosure to patients.
Learn more about this trial
CSII Versus MDI in Pregnant Women With Type 2 Diabetes
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