Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study

NCT05123248 | Completed DMC

• 1 other identifier: 2018/2128
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the following hypotheses in a longitudinal, observational study in pregnant women who will be randomized to received either a Blinded or Unblinded CGM sensor and followed-up 6-12 weeks after delivery:

1. 1.CF-CGM device is well tolerable and accurate for glucose level monitoring in women with a normal pregnancy.
2. 2.CF-CGM device is well tolerable and acceptable in women with GDM who are required intensive glucose monitoring on a daily basis during pregnancy and even after delivery.
3. 3.There are trimester-specific glucose profiles observed in the whole pregnancy.
4. 4.Pregnancies complicated with GDM would show a specific glucose profile that is different from non-GDM pregnancies (e.g. greater daily fluctuations, more episodes and longer duration of glucose spikes after meal).
5. 5.There is a good correlation between one-day glucose profile and OGTT test at 24-31 weeks gestation GDM screening.
6. 6.Pre-GDM screening glucose profiles is predictive of GDM diagnosis at 24-31 weeks gestation.

Conditions

Gestational Diabetes; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Gestational Diabetes Mellitus (GDM)

  Clinical outcomes of Gestational Diabetes Mellitus (GDM) development determined by oral glucose tolerance test

  24-31 weeks gestation

Secondary Outcomes (2)

• CGM summary metrics derived from extracted CGM glucose data

  First trimester: 9-13 weeks, Second trimester: 18-23 weeks, 24-31 weeks, 32-33 weeks

• Plasma glucose measures from OGTT

  24-31 weeks gestation

Other Outcomes (4)

• Applicability, acceptability, compliance of the blinded the CGM device use in a normal pregnancy.

  At 32-33 weeks gestation

• Applicability, acceptability, compliance of the unblinded the CGM device use in a normal pregnancy.

  At 32-33 weeks gestation

• Applicability, acceptability, compliance of the blinded CGM device use in a GDM pregnancy

  6-12 weeks postnatal

Study Arms (2)

Blinded Group

EXPERIMENTAL

Participants in the blinded group will be wearing the sensor for 14 days without a reader. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader.

Device: Blinded Group

Unblinded Group

EXPERIMENTAL

Participants in the non-blinded group are required to wear the sensor for 14 days with an open reader. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided.

Device: Unblinded group

Interventions

Blinded Group DEVICE

Participants in the blinded group will be wearing the sensor for 14 days without a reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader.

Blinded Group

Unblinded group DEVICE

Participants in the non-blinded group are required to wear the CGM sensor for 14 days with an open reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided.

Unblinded Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are Singapore citizens or Singapore Permanent Residents, and plan to be followed up throughout pregnancy and intend to deliver at KKH;
• Aged 21 and above;
• Singleton pregnancy

You may not qualify if:

• Have serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days;
• Patients who have any other chronic disease such as chronic kidney disease.
• Unable to read or speak English

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

• Quah PL, Tan LK, Thain SPT, Lek N, Tagore S, Chern BSM, Ang SB, Wright A, Jong M, Tan KH. First Trimester Mean Glucose Level on Continuous Glucose Monitoring Is Associated with Infant Birth Weight. Diabetes Metab J. 2025 Nov;49(6):1262-1271. doi: 10.4093/dmj.2024.0700. Epub 2025 Jun 2.

  PMID: 40452210 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Participants randomized to both the non-blinded continous glucose monitoring sensors and the blinded continous glucose monitoring sensors.

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 17, 2021
• Study Start: October 16, 2018
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)