CSII Versus MDI in Pregnant Women With Type 2 Diabetes

NCT05001815 | Unknown DMC

• 1 other identifier: 2021NFM001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Pregnancy in Diabetic

Keywords

type 2 diabetes; pregnancy; continuous subcutaneous insulin infusion; multiple daily injection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  34 weeks of gestation

Secondary Outcomes (23)

• Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin

  24, 28, 34 weeks of gestation and 6 weeks of postpartum

• TIR calculated by patients' SMBG data

  At 4 weeks after randomization, and at 24, 28, 34 and 38 weeks of gestation

• TAR and TBR

  At 24, 28 and 34 weeks of gestation

• Blood glucose fluctuation index

  At 24, 28 and 34 weeks of gestation

• The AUC of blood glucose within 24 hours before delivery

  Within 24 hours before delivery

Study Arms (2)

Continuous subcutaneous insulin infusion (CSII)

EXPERIMENTAL

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

Device: Continuous subcutaneous insulin infusion (CSII)

Multiple daily insulin injection (MDI)

ACTIVE COMPARATOR

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

Device: Multiple daily insulin injection (MDI)

Interventions

Continuous subcutaneous insulin infusion (CSII) DEVICE

The CSII device used in this study has access to mobile phone, however, without CGM enhanced function

Continuous subcutaneous insulin infusion (CSII)

Multiple daily insulin injection (MDI) DEVICE

Patients with indication will receive MDI treatment with at least one basal insulin injection plus 2 to 3 prandial insulin injection.

Multiple daily insulin injection (MDI)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Haining Wang, MD and Ph.D

CONTACT

+86-18211087263; hainingmail@bjmu.edu.cn

Ran Lu, MD

CONTACT

+86-01082265025; luransurf@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 12, 2021
• Study Start: December 15, 2021
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)