Gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
Study design
This study is a randomised controlled trial. 40 participants will be recruited, so that there are 20 participants in each arm. This is based on sample calculation, and all
Sponsors
Portsmouth Hospitals NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female, aged 18 years or above 2. Currently pregnant, and between 26 to 30 weeks gestation 3. Currently diagnosed with first episode of gestational diabetes 4. Are suitable to follow the standard care pathway in JDANC for gestational diabetes and undertake SMBG 5. Participant is willing and able to give informed consent for participation in the study
Exclusion criteria
Exclusion criteria: 1. Pre-existing known diabetes that is not gestational 2. Previous gestational diabetes 3. Not able to perform SMBG for any reason 4. Previous or current pre-eclampsia 5. Previous or currently diagnosed hypertension 6. Known allergy to Freestyle Libre adhesive pad 7. Planning to move to a geographical area not covered by Portsmouth Hospitals NHS Trust before the end of the study 8. Participating in another study that could interfere with glucose levels or affect ability to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean number of daily glucose readings in CGM group compared to SMBG group measured between weeks 30 to 36 gestation (+/- 14 days); Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The following endpoints will be used for comparisons between the CGM and SMBG groups: 1. Drug (metformin and insulin) doses at each clinic visit 2. SMBG data (downloaded via Diasend) and CGM data (downloaded via Freestyle Libre software) 3. AGP metrics (see below) at weeks 26 to 28 and 36 to 38 gestation (approximately) and postpartum (for extended subgroup) 4. Recorded maternal and fetal adverse outcomes and fetal size after delivery 5. Patient satisfaction questionnaire at week 36 gestation 6. Clinical measurements including HbA1c, weight and height 7. Recorded therapy initiation and dose adjustment at each clinic visit AGP metrics measured by the Freestyle Libre flash glucose monitor will be used in the endpoint analysis and comparisons: 1. Mean interquartile range 2. Area under the median curve (AUC) 3. Median 4. Time above target range (above 10 mmol/L and above 1 5 mmol/L) 5. Time in target range (TIR) (4-10 mmol/L) 6. Time below target range (below 4 mmol/L and below 3 mmol/L) 7. Median curve instability 8. Specific time periods – including preprandial and postprandial 9. Estimated HbA1c CGM postpartum sub-group: Postpartum AGP metrics | — |
Countries
United Kingdom
Outcome results
None listed