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A randomized controlled trial to evaluate the efficacy of continuous glucose monitoring system for perinatal outcome and glycemic control in women with gestational diabetes mellitus and pregnant women with type 2 diabetes

Efficacy of continuous glucose monitoring in pregnant women with GDM or type 2 diabetes

Horie Ichiro

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki

horie@nagasaki-u.ac.jp

Horie Ichiro

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki

+81-958197200

horie@nagasaki-u.ac.jp

Recruiting

Mar. 12, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1)Pregnant Japanese women (both parents and grandparents are Japanese) who are either:Diagnosed with type 2 diabetes or diagnosed with gestational diabetes mellitus (GDM) and are receiving outpatient or inpatient care at the Department of Endocrinology and Metabolism or the Department of Obstetrics and Gynecology at Nagasaki University Hospital.
2)Pregnancy type: Singleton pregnancy.
3)Age: Pregnant women aged 18 years or older at the time of obtaining consent.
4)Gestational age: No restrictions.
5)Inpatient/Outpatient status: No restrictions.
6)Eligibility at the time of consent:
Those who fully understand the importance of dietary therapy during pregnancy and are willing to implement it.
Those who can undergo insulin therapy if blood glucose control through dietary therapy is insufficient.
Those who are able to use continuous glucose monitoring (CGM) devices and self-monitoring of blood glucose (SMBG) devices via fingerstick.
7)Written informed consent is obtained from the patient herself regarding participation in the study

1)Patients with a history of previous use of CGM
2)Pregnant women with conditions other than type 2 diabetes or GDM that require treatment.
3)Patients who have experienced contact dermatitis caused by the Dexcom G7 sensor in the past.
4)Patients who are currently participating or plan to participate in other clinical trials or clinical studies involving medical devices or pharmaceuticals at the time of obtaining consent or during the pregnancy.
5)Other patients deemed unsuitable as study participants by the principal investigator or sub-investigator.

Female

Gestational diabetes mellitus and type 2 diabetes in pregnancy

The participants will be allocated in a 1:1 ratio to either the CGM group or the control group through a randomization process.The subjects allocated in the CGM group will be instructed glucose monitoring using the Dexcom G7 CGM system, and the subjects allocated in the control group will be instructed glucose monitoring using fingerstick testing.

Achievement rate of glycoalbumin < 15.8% at 36 weeks of gestation

<Maternal Diabetes-Related Outcomes>
Glycoalbumin levels (%) at gestational weeks 24, 28, 32, 36, and 40, as well as the changes in glycoalbumin levels (%) from study initiation (start of treatment).
HbA1c levels (%) at gestational weeks 24, 28, 32, 36, and 40, as well as the changes in HbA1c levels (%) from study initiation (start of treatment).
Achievement rate of HbA1c < 6.0% at 36 weeks of gestation.
CGM data (TBR, TIR, TAR, MARD, GMI, SD, %CV, MAGE) at gestational weeks 24, 28, 32, 36, 40, and postpartum.
Insulin initiation rate (%) during pregnancy.
Maximum insulin requirement (units/day, units/kg/day) during pregnancy.
Incidence of severe hypoglycemia (<54 mg/dL or hypoglycemia with impaired consciousness) during pregnancy.
Total weight gain during pregnancy and weight gain from study initiation (start of treatment).

<Perinatal Outcomes>
Gestational age at delivery, rates of cesarean delivery, neonatal birth weight, apgar scores (1 minute, 5 minutes), rates of large for gestational age (LGA) and small for gestational age (SGA) infants, NICU admission rate, neonatal hypoglycemia rate, neonatal jaundice, shoulder dystocia, preterm delivery, stillbirth and neonatal death, composite perinatal outcome (rates of LGA, SGA, NICU admission, neonatal hypoglycemia, neonatal jaundice, shoulder dystocia, preterm birth, stillbirth, and neonatal death).

<Maternal QOL Outcomes>
Maternal QOL scores (DTSQ, DTR-QOL, HFS-II), average frequency of SMBG usage (times/day) during pregnancy.

+81-95-819-7229

Feb. 27, 2025

Yes

If a third party requests the sharing or publication of individual participant data (IPD), the principal investigator will review the purpose and scope of use. If deemed appropriate, the data will be shared or published through the necessary procedures.

none