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Study of the accuracy of a home oral glucose tolerance test kit

Study of the accuracy of the GTT@home oral glucose tolerance test kit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66273796
Enrollment
65
Registered
2023-05-16
Start date
2023-03-08
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy

Interventions

A total of 65 women who meet the inclusion/exclusion criteria will have a glucose tolerance test. Fingerprick blood capillary blood samples will be measured using the GTT@home device. Venous blood sam

Sponsors

Digostics Ltd
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Age greater than or equal to 18 years 3. BMI above 20 kg/m² 4. Previous macrosomic baby weighing greater than or equal to 4.5 kg or the 90th centile 5. Previous gestational diabetes 6. Family history of diabetes (first-degree relative with diabetes) 7. An ethnicity with a high prevalence of diabetes 8. Written, signed, informed consent

Exclusion criteria

Exclusion criteria: 1. Unable or unwilling to sign informed consent

Design outcomes

Primary

MeasureTime frame
Accuracy measured by comparison of the categories of normal glucose tolerance and glucose intolerance using venous and capillary blood glucose readings at fasting and 2 hours

Secondary

MeasureTime frame
1. Sensitivity measured by comparison of the categories of normal glucose tolerance and glucose intolerance using venous and capillary blood glucose readings at fasting and 2 hours 2. Specificity measured by comparison of the categories of normal glucose tolerance and glucose intolerance using venous and capillary blood glucose readings at fasting and 2 hours

Countries

United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026