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Towards Precision Medicine for Diabetes in Pregnancy

Towards Precision Medicine for Diabetes in Pregnancy - ToPMedDiP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51350
Enrollment
45
Registered
2022-08-11
Start date
2023-10-30
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes in Pregnancy Gestational Diabetes

Interventions

None listed

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: having a confirmed single, viable pregnancy past 20 weeks gestation Diagnosed GDM and treated with Metformin (as prescribed by Ob/Gyn)

Exclusion criteria

Exclusion criteria: pre-existing diabetes

Design outcomes

Primary

MeasureTime frame
Study parameters will be collected at mid-gestation (24-27 weeks), end gestation (35-37 weeks), and 6 weeks after delivery, as indicated in Table 1. Primary outcomes of this study will be time in range during 7 days continuous glucose monitoring. Requirement for additional insulin-treatment will be abstracted from medical records and reported in %.

Secondary

MeasureTime frame
Insulin sensitivity and sensitivity will be calculated as Matsuda-Index and Stumvoll-indices, using the available samples of the routine OGTT, namely 0, 60 and 120 min: Matsuda = 10,000/ SQRT(Gluc0 * INS0 * Glucmean * INSmean); Stumvoll(1st) = 1194 + 4.724 × Ins0 * 117.0 × Gluc60 + 1.414 × Ins60. Women will be classified as having low insulin secretion and/or low insulin sensitivity as

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)