Individualised patient care and treatment for maternal diabetes

Not Applicable

• Conditions: Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN57579163
• Lead Sponsor: niversity of Leeds

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36849210/ (added 28/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-25
• Last Update Posted: 13 March 2023
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

1. Women aged 18-45 years
2. Singleton pregnancy
3. Pregnant women in the first trimester of pregnancy
4. Diagnosed with either type 1 or type 2 diabetes mellitus

Exclusion Criteria

1. Women aged under 18 or above 45 years
2. Women presenting after 14 weeks gestation
3. Multiple pregnancy
4. Foetal congenital abnormality
5. No diagnosis of diabetes
6. Diagnosis of gestational diabetes
7. Significant co-existent medical condition (e.g. overt diabetes complications, cancer, gut mobility or digestion disorder)
8. Significant psychological (e.g. anorexia, bulimia) and/or mental disorders which undermines informed consent
9. Dietary allergies or intolerance (for the standardised meals
10. Lack of internet access on a computer or tablet at home
11. Unable to understand written English and provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measures of (dys)glycaemia (e.g. CGM data, HbA1c) accessed at approximately 10-12, 18-20, and 28-34 weeks' gestation

Secondary Outcome Measures

Name	Time	Method
<br> 1. Medical details of health, pregnancy, and delivery collected via routine care at the diabetes in pregnancy clinic at Leeds Teaching Hospitals NHS Trust on three occasions at ~10-12, 18-20, and 28-34 weeks of gestation<br> 2. Lifestyle information:<br> 2.1. Maternal dietary intake recorded using the myFood24 app over 3 days (2 weekdays and 1 weekend)<br> 2.2. Physical activity and sleep recorded using Pregnancy Physical Activity Questionnaire (PPAQ) and Leeds Sleep Evaluation Questionnaire (LSEQ) questionnaires, respectively, on three occasions at ~10-12, 18-20, and 28-34 weeks of gestation<br> 3. Metabolomics and genetic analysis using urine and blood samples on three occasions at ~10-12, 18-20, and 28-34 weeks of gestation<br>