CGM Accuracy in Pregnancy Study

NCT07269015 | Not Yet Recruiting

• 1 other identifier: P/25-041
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy in women with diabetes remains a high-risk condition, requiring strict glycemic control due to rapid physiological changes that affect insulin sensitivity. Continuous glucose monitoring (CGM) provides detailed glucose trends, but the accuracy of newer, affordable systems such as Dexcom One Plus and FreeStyle Libre 2 Plus has not been evaluated during pregnancy. This prospective interventional study aims to compare the accuracy of these two CGM systems-both worn simultaneously-using capillary glucose as the reference. The study also evaluates educational needs, skills, attitudes, digital competence, lifestyle habits, and patient-reported outcomes among pregnant women with type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes (GDM).

Conditions

Pregestational Diabetes; Continuous Glucose Monitoring

Keywords

type 2 diabetes; continuous glucose monitoring; pregnancy

Outcome Measures

Primary Outcomes (2)

• Mean Absolute Relative Difference (MARD)

  Difference between paired continuous glucose monitoring (CGM) readings (Dexcom One Plus vs. FreeStyle Libre 2 Plus) and reference capillary glucose values.

  End of 30-day monitoring period; Primary outcome

• Baseline diabetes knowledge, skills, and attitudes

  For the baseline evaluation, a specific questionnaire for the present study was administered, and the Spanish version of the Cambados Questionnaire will also be used. The Cambados Questionnaire is a 5-item questionnaire designed to assess digital competence. The score range is from 0 to 20. Higher scores indicate greater digital competence.

  Baseline (first study visit)

Secondary Outcomes (6)

• Mean Absolute Difference (MAD) for glucose <70 mg/dL

  End of 30-day monitoring period

• Agreement rates (15/15%, 20/20%, 40/40%) across glucose ranges

  End of 30-day monitoring period

• Dietary habits (Mediterranean diet adherence)

  Baseline and End of 30-day monitoring period

• Physical activity

  7 days before baseline and through study completion, an average of 1 week

• Sleep quality

  Baseline and through study completion, an average of 1 week

Study Arms (1)

Dual Continuous Glucose Monitoring Use

EXPERIMENTAL

All participants will wear two continuous glucose monitoring sensors simultaneously

Device: Dexcom One Plus; Device: FreeStyle Libre 2 Plus; Procedure: Additional Study Procedures

Interventions

FreeStyle Libre 2 Plus DEVICE

Worn on the opposite arm for 15 days One replacement during the 30-day study period Used as real-time CGM via LibreLink

Dual Continuous Glucose Monitoring Use

Additional Study Procedures PROCEDURE

Capillary glucose monitoring before meals, 1 hour postprandially, and during symptoms of hypoglycemia (Contour Instant) One baseline structured education session for participants without prior CGM experience Routine diabetes education according to national guidelines

Dual Continuous Glucose Monitoring Use

Dexcom One Plus DEVICE

Worn on the upper arm for 10 days Two replacements during the 30-day study period Used with Dexcom mobile application

Dual Continuous Glucose Monitoring Use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with type 1 diabetes, type 2 diabetes, or gestational diabetes, diagnosed before 32 weeks of gestation
• Age ≥18 years
• Willingness to wear two CGM systems simultaneously
• Possession of a smartphone compatible with LibreLink
• Ability to sign informed consent

You may not qualify if:

• Comorbidities affecting glucose metabolism
• Inability to use CGM devices or perform capillary glucose testing

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (6)

• Driesman AS, Konopka JA, Feder O, Aggarwal V, Schwarzkopf R. Management Principles of Massive Acetabular Bone Loss in Revision Total Hip Arthroplasty A Review of the Literature. Bull Hosp Jt Dis (2013). 2023 Mar;81(1):4-10.

  PMID: 36821729 BACKGROUND

• Dai J, Liu D, Yin X, Wen X, Cai G, Zheng L. Anisotropic Elastomer Ionomer Composite-Based Strain Sensors: Achieving High Sensitivity and Wide Detection for Human Motion Detection and Wireless Transmission. ACS Sens. 2024 Apr 26;9(4):2156-2165. doi: 10.1021/acssensors.4c00274. Epub 2024 Apr 17.

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• Lin S, Pan X, Meng D, Zhang T. Electric conversion treatment of cobalt-containing wastewater. Water Sci Technol. 2021 Apr;83(8):1973-1986. doi: 10.2166/wst.2021.101.

  PMID: 33905366 BACKGROUND

• Kawada T. Psychosocial factors and mortality in patients with heart failure. Eur J Heart Fail. 2018 Aug;20(8):1243. doi: 10.1002/ejhf.1208. Epub 2018 Apr 24. No abstract available.

  PMID: 29693755 BACKGROUND

• Murphy HR, Howgate C, O'Keefe J, Myers J, Morgan M, Coleman MA, Jolly M, Valabhji J, Scott EM, Knighton P, Young B, Lewis-Barned N; National Pregnancy in Diabetes (NPID) advisory group. Characteristics and outcomes of pregnant women with type 1 or type 2 diabetes: a 5-year national population-based cohort study. Lancet Diabetes Endocrinol. 2021 Mar;9(3):153-164. doi: 10.1016/S2213-8587(20)30406-X. Epub 2021 Jan 28.

  PMID: 33516295 BACKGROUND

• Simmons D, Immanuel J, Hague WM, Teede H, Nolan CJ, Peek MJ, Flack JR, McLean M, Wong V, Hibbert E, Kautzky-Willer A, Harreiter J, Backman H, Gianatti E, Sweeting A, Mohan V, Enticott J, Cheung NW; TOBOGM Research Group. Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy. N Engl J Med. 2023 Jun 8;388(23):2132-2144. doi: 10.1056/NEJMoa2214956. Epub 2023 May 5.

  PMID: 37144983 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Verónica Perea, MD, PhD

CONTACT

0043937 36 50 50; vperea@mutuaterrassa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive both sensors simultaneously

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)