Pregnant women with type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
Fitness trackers will be given to consented participants by the Researcher at the start of the period of data collection, that is gestational week 9-11. Participants will be asked to wear the device o
Sponsors
University of Ulster
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with T1D in the first trimester of pregnancy 2. Aged 18 - 50 years old 3. Duration of diabetes >1 year 4. Using multiple daily injections or insulin pump therapy 5. Using an interstitial glucose sensor 6. BMI <40 kg/m² 7. Have undertaken a program of structured education for carbohydrate counting 8. Able to understand English
Exclusion criteria
Exclusion criteria: 1. Less than 18 years of age 2. Type 2 diabetes (T2D) or a genetic variant of diabetes 3. Diagnosed 13 weeks pregnant at the time of presenting to the antenatal clinic 7. Unable to read or understand English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time spent in the optimum glucose range of 3.5 mmol/mol - 7.8 mmol/mol measured using the Abbott FreeStyle Libre 14-day glucose sensor as a percentage at three timepoints, i.e. weeks 9-13, 20-24 and 32-36 2. HbA1c in mmol/mol gathered from Laboratory Reports filed in the Northern Ireland Regional handheld maternity records (readings obtained from capillary blood glucose samples as part of the routine care pathway within the antenatal clinic) between weeks 9-13, 20-24 and 32-36 3. Number of hypoglycaemic/hyperglycaemic episodes in minutes per day as a percentage of time measured using the Abbott FreeStyle Libre 14-day glucose sensor between weeks 9-13, 20-24 and 32-36 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcome measures (except 8) are collated from written/printed records within the Northern Ireland Regional handheld maternity records. These contain NIMATS (Northern Ireland MATernity System) antenatal, intranatal, postnatal and neonatal reports as well as Lab reports for all blood results: 1. Pre-eclampsia defined as new-onset hypertension with simultaneous proteinuria developing at any point from 20 weeks' gestation 2. Mode of delivery, i.e. vaginal, instrumental - forceps or ventouse, elective caesarean section emergency caesarean section as a percentage of participant outcomes measured at the time of birth 3. Gestational age in completed weeks and days measured at the time of birth 4. Live born infants, number and percentage measured at the time of birth 5. Infant birthweight in grams, measured at the time of birth 6. Perinatal mortality, number and percentage of births measured from 20 weeks' gestation until 7 days after the birth 7. Neonatal death, in numbers and percentage measured from 7 days after birth until 28 days after birth 8. Neonatal blood glucose levels in mmol/mol, collated from the Neonatal Hypoglycaemia Pathway within each infant's neonatal chart (neonatal glucose levels measured using the Abbott FreeStyle Precision Pro glucometer) within 3 hours of birth and during the first 48 hours of life 9. Maternal weight change in kg measured at the booking visit and on admission to the delivery suite for induction of labour, or in spontaneous labour, or for elective caesarean section. Mothers undergoing emergency caesarean section will have been weighed on admission to the delivery suite as per the hospital protocol | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactDawn Adams
Outcome results
None listed