Gestational diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Intermittently scanned continuous blood glucose monitoring device (Freestyle Libre2). Administered approximately 1-2 weeks post-diagnosis, following commencement of metformin or insulin. Worn for the
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 16 - 55 years old 2. GDM diagnosed at any gestation >12 weeks per NICE guidelines: oral glucose tolerance test demonstrating a fasting plasma glucose level of 5.6 mmol/litre or above or a 2-hour plasma glucose level of 7.8 mmol/litre or above 3. Up to 32+0 weeks of gestation 4. Diagnosed within the last 14 days 5. Primiparous or multiparous 6. Singleton pregnancy 7. Not met NICE glucose targets with lifestyle modification of fasting glucose below 5.3mmol/litre, 1 hour after meals below 7.8mmol/l OR 2 hours after meals below 6.4mmol/litre 8. Commenced insulin and/or at least 500mg/day of metformin 9. Able to give informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Aged 55 years old 2. Pre-existing overt diabetes (OGTT- fasting =7 mmol/L or 2 hour =11.1 mmol/Lor HbA1C >48) 3. >32+0 weeks gestation 4. Diagnosis of GDM >14 days 5. Chronic kidney disease 6. Psychiatric inpatient treatment 7. History of bariatric surgery or other surgeries that induce malabsorption 8. Long-term use(>2 weeks) of systemic steroids within 2 weeks prior to enrolment 9. Multiple pregnancies 10. Met NICE glucose targets with lifestyle modification 11. Not prescribed insulin or at least 500mg/day of metformin 12. Unable to give informed consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes measured using data recorded in the study screening log at the end of the study: 1. Absolute number of recruits 2. Recruitment rate 3. Number of women invited to study 4. Number of women meeting eligibility criteria 5. Follow-up rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical fetal/neonatal outcomes (at birth and 6-8 weeks postnatal where indicated) measured using the participants’ clinical record: 1. Birth centile including large and small for gestational age (LGA; SGA); Intergrowth birth centile chart. LGA >90th centile SGA4kg (Yes/No) at birth 4. Anthropometry: Head, chest, abdominal circumference (cm); crown-rump length, crown-heel length at birth and weight and head circumference at birth and 6-8 weeks postnatal 5. Miscarriage before 23+6 gestation (Yes/No) recorded when the event arises 6. Stillbirth after 24+0 gestation (Yes/No) recorded when the event arises 7. Neonatal death <28 days of life (Yes/No) recorded when the event arises 8. Preterm birth <37 weeks’ gestation at birth (Yes/No) at birth 9. Gestation at birth (weeks) at birth 10. NICU admission (Yes/No) and length of stay in days at birth 11. Umbilical cord pH at birth 12. Apgar score at 0, 5, and 10 minutes at birth 13. Injury: clavicle, humeral, skull fracture (Yes/No) at birth 14. Hypoglycaemia requiring NICU treatment (Yes/No) at birth 15. Treatment for Respiratory distress syndrome (Yes/No) at birth 16. Treatment for hyperbilirubinaemia (Yes/No) at birth Clinical maternal outcomes measured using data recorded in Clinical records: 17. Weight (kg) at booking and 34-36 weeks 18. Height (cm) at booking and 34-36 weeks 19. Diabetes medications prescribed (type, quantity) at each appointment 20. Hypoglycaemic episodes (if on insulin) (number/ frequency) at each appointment 21. Other adverse events (e.g. skin irritation) at each appointment 22. Glycaemic control: 22.1. HbA1c baseline at 34-36 weeks and 6-13 weeks postnatal for both groups 22.2. SMBG daily diaries – fasting and post-meal glucose. Each antenatal appointment (SMBG group only) 22.3. Continuous glucose data - % time in target range (3.5-7.8mmol/l), area under curve, % time in hypo- and hyperglycaemia, standard deviation and amplitude of glycaemic excursions at baseline and 34-36 weeks for both groups | — |
Countries
England, United Kingdom
Contacts
Public ContactAbi Loose
Outcome results
None listed