Continuous glucose monitoring amongst pregnant women with early-onset type 2 diabetes
| ISRCTN | ISRCTN12804317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12804317 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 331906 |
| Protocol serial number | CPMS 58352, NIHR150958, IRAS 331906 |
| Sponsor | University of East Anglia |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) |
- Submission date
- 19/10/2023
- Registration date
- 23/10/2023
- Last edited
- 12/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Previous studies have shown that Continuous Glucose Monitoring (CGM) improves maternal glucose, reduces neonatal admissions and is clinically and cost-effective in type 1 diabetes (T1D) pregnancy, and as a result CGM is now standard care in T1D pregnancy. However, there are no well-designed adequately powered trials to compare CGM and standard care monitoring of blood glucose in type 2 diabetes (T2D) pregnancy.
The purpose of this study is to examine whether using CGM improves glucose levels in pregnant women with T2D and whether it leads to better outcomes for the baby. We will also look at its impact on maternal wellbeing, diabetes treatment satisfaction, and cost effectiveness.
Who can participate?
We are aiming to recruit 422 pregnant women aged 16 years and above with T2D.
What does the study involve?
Eligible participants will be approached early in pregnancy and if consent is given they will be enrolled. All participants will wear a masked sensor for 4-14 days to collect baseline CGM data. Participants will then be randomly allocated to receive either study CGM or standard of care (finger-prick blood glucose monitoring) for the rest of pregnancy.
Study visits are aligned with routine antenatal visits every 4 weeks. An optional blood sample for metabolic phenotyping will be obtained, usually at the recruitment visit. The participant will be asked to complete questionnaires at the recruitment visit and then again at around 32 weeks' gestation. Blood samples for HbA1c will be taken at baseline, 28-week, 32-week, and 36-week visits. Participants in the control arm will wear a masked sensor for 14 days at 20, 28, 32 and 36 weeks' gestation. Following delivery we will collect information on birth and infant. 20-25 participants will also be interviewed towards the end of pregnancy, or post-partum, to examine, among other things, barriers and facilitators for CGM use in this population.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
May 2023 to April 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Corinne Collett, C.Collett@uea.ac.uk
protect.trial@uea.ac.uk
Contact information
Scientific, Principal investigator
Norwich Medical School, Floor 2, Bob Champion Research and Education Building, University of East Anglia, Norwich Research Park
Norwich
NR4 7UQ
United Kingdom
 ORCID ID |
0000-0002-5489-0614 |
|---|---|
| Phone | +44 (0)1603 591657 |
| Helen.Murphy@uea.ac.uk |
Scientific, Principal investigator
LICAMM, LIGHT Laboratories, Clarendon Way, University of Leeds
Leeds
LS2 9JT
United Kingdom
| ORCID ID |
0000-0001-5395-8261 |
|---|---|
| Phone | +44 (0)113 343 7762 |
| E.M.Scott@leeds.ac.uk |
Public
Norwich Clinical Trials Unit
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| ORCID ID |
0000-0002-5510-1488 |
|---|---|
| C.Collett@uea.ac.uk |
Public
Norwich Clinical Trials Unit
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| protect.trial@uea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | PRegnancy Outcomes using continuous glucose monitoring TEChnology in pregnant women with early-onset Type 2 diabetes: A multicentre randomised controlled trial of the clinical and cost-effectiveness of using continuous glucose monitoring (CGM) in pregnant women with early-onset type 2 diabetes |
| Study acronym | PROTECT |
| Study objectives | In pregnant women with early-onset type 2 diabetes, the use of real-time CGM is more effective than standard clinical care (finger-prick self-monitoring blood glucose testing, continuous glucose monitoring) for improving the percentage of time spent in the pregnancy target glucose range of 3.5-7.8 mmol/L and reducing clinically relevant neonatal morbidity (neonatal care admission) or perinatal death. |
| Ethics approval(s) |
Approved 19/09/2023, South Central - Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048276; berkshireb.rec@hra.nhs.uk), ref: 23/SC/0315 |
| Health condition(s) or problem(s) studied | Early-onset type 2 diabetes in pregnancy |
| Intervention | Recruitment visit: When women have expressed their wish to participate, they will be invited for the recruitment visit, when the following activities will be performed by the research team: • Checking inclusion and exclusion criteria • Written informed consent • Baseline socio-demographic data collection • Relevant medical / obstetric history and present medical (diabetes, comorbidity, medication, and obstetric) information • Body weight and height, calculation of BMI • Early pregnancy HbA1c recorded (or performed if not previously done in this pregnancy) • Blood sample taken for metabolic phenotyping (C-peptide, autoantibodies, genetic risk score) • Baseline questionnaire pack provided for participants to complete at home (either paper or electronically via link) • Masked Freestyle Libre 3 sensor insertion (ideally 2 weeks prior to randomisation) Women will have a small glucose sensor inserted under the skin by the clinical research team and will be instructed to wear it at home for up to 14 days. They will not be able to see the glucose information from this sensor. Randomisation visit: Ideally the sensor will be in place for 14 days, however if necessary to meet timelines, at least 3-4 days of CGM data should be available prior to randomisation (prior to 16 weeks' gestation). At the randomisation visit, the following will be performed: • Masked CGM sensor upload & review (to confirm adequate baseline data available). Those randomised to the intervention arm will have access to the data from the masked sensor period following randomisation. • Collection / confirmation of completed baseline questionnaires • Record average total daily dose (TDD) of insulin during the previous 3 days • Randomisation via study website • Participant training Participants in the CGM group will be shown how to apply the sensor, how to understand and use the CGM apps, how to interpret the data to guide decisions on eating and activity, recommended targets, and metformin / insulin dose adjustment. Participants in the control arm will receive fingerstick self-monitoring blood glucose or continuous glucose monitoring training per local standard of care, along with advice on recommended targets, managing their diabetes in pregnancy, and metformin/insulin dose adjustment if relevant. Participants will use their allocated glucose monitoring method throughout pregnancy, until after delivery. Subsequent Study Visits Follow up visits will be every 4 weeks at ~16/40, 20/40, 24/40, 28/40, 32/40, 36/40. It is expected that study visits will align with routine NHS antenatal clinic visits however virtual study visits will be offered if appropriate. At these visits the following data will be recorded on the study database: • Weight • Blood pressure • Glucose monitoring method(s), frequency of glucose testing • Insulin delivery method(s), dose and type • Adverse events of special interest In addition, the following will be performed at key visits: • Masked CGM for control group participants (14 days data collection) at 20, 28, 32, and 36 weeks’ gestation • Blood collection for HbA1c at 28, 32, and 36 weeks’ gestation • Follow-up questionnaires at 32 weeks’ gestation Delivery visit The following obstetric and neonatal outcomes will be collected: • Mode of delivery (vaginal, instrumental, elective/emergency caesarean section) • Gestational age at delivery and indication for any preterm delivery <37 weeks • Infant(s) birth weight • Adverse events (pregnancy loss <24 weeks, stillbirth, neonatal death) Neonatal follow up Neonatal assessment is at hospital discharge (or 28 days if admission prolonged). The following data will be collected: • Neonatal morbidity (treatment for neonatal hypoglycaemia, neonatal jaundice, respiratory distress) • Neonatal care admission (duration of stay at each level of care) • Infant feeding at hospital discharge • Neonatal readmission in first 7 days after birth Questionnaires Participants will be asked to complete questionnaires at home, electronically or on paper, at baseline and again at 32 weeks: • T2D Distress Scale (DDS) • Glucose Monitoring Satisfaction Survey (GMSS) • Patient Health Questionnaire 9-item depression scale (PHQ-9) • Generalized Anxiety Disorder 7-item scale (GAD-7) • EQ-5D Optional qualitative interviews 20-25 participants will be purposively selected by socio-demographic factors to take part in the semi-structured interviews, in early pregnancy (after randomisation) and again at around 32-36 weeks' gestation. Interviews will take place remotely or in person. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Continuous glucose monitoring |
| Primary outcome measure(s) |
1. Percentage time spent with maternal glucose levels within target range as recorded by CGM Time-In-Range (TIR 3.5-7.8mmol/l) from 20 until 38 weeks’ gestation or until delivery, if delivery is earlier than 38 weeks’ gestation |
| Key secondary outcome measure(s) |
1. HbA1c & CGM mean glucose, GMI, frequency & duration of glycaemic excursions [%Time-Above-Range (≥6.7 & ≥7.8mmol/L), %Time-Below-Range (≤3.5 & ≤3.0mmol/l)], glycaemic variability (glucose SD, CV)] From 20 until 38 weeks’ gestation or until delivery, if delivery is earlier than 38 weeks’ gestation |
| Completion date | 30/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 120 Years |
| Sex | Female |
| Target sample size at registration | 422 |
| Key inclusion criteria | Current key inclusion criteria as of 12/03/2026: 1. Type 2 diabetes (T2D) 2. 16 years of age or over 3. Confirmed pregnancy 4. HbA1c of > = 43 mmol/mol (6.1%) in pregnancy (prior to randomisation) 5. Willingness to use the study devices throughout the trial 6. Able to provide informed consent 7. 4 days (aiming for ≥96 hours) of baseline CGM data before randomisation at no later than 16+0 weeks’ gestation. In cases where 72-96 hours of CGM data is available, inclusion may be approved by the NCTU team _____ Previous key inclusion criteria: 1. Type 2 diabetes (T2D) 2. 16 years of age or over 3. Confirmed pregnancy < = 14 weeks’ gestation 4. HbA1c of >=43 mmol/mol (6.1%) in pregnancy (<=14 weeks’ gestation) 5. Willingness to use the study devices throughout the trial 6. Able to provide informed consent |
| Key exclusion criteria | Current key exclusion criteria of of 12/03/2026: 1. Non-type 2 diabetes 2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min) _____ Previous key exclusion criteria: 1. Non-type 2 diabetes 2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min) 3. Severe visual impairment |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Colney
Norwich
NR4 7UY
England
Beckett Street
Leeds
LS9 7TF
England
London
NW1 2PG
England
Birmingham
B4 6NH
England
Infirmary Square
Leicester
LE1 5WW
England
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
England
St Marys Hospital
South Wharf Road
London
W2 1BL
England
Eaglestone
Milton Keynes
MK6 5LD
England
Oxford Road
Manchester
M13 9WL
England
Duckworth Lane
Bradford
BD9 6RJ
England
Herries Road
Sheffield
S5 7AU
England
80 Newark Street
London
E1 2ES
England
Crown Street
Liverpool
L8 7SS
England
369 Fulham Road
London
SW10 9NH
England
Uttoxeter Road
Derby
DE22 3NE
England
530 London Road
Thornton Heath
CR7 7YE
England
Headley Way
Headington
Oxford
OX3 9DU
England
Glen Road
London
E13 8SL
England
Isleworth
TW7 6AF
England
Halifax Road
Dewsbury
WF13 4HS
England
Southgate
Pontefract
WF8 1PL
England
Wakefield
WF1 4DG
England
Stevenage
SG1 4AB
England
Welwyn Garden City
AL7 4HQ
England
Boston
PE21 9QS
England
Lincoln
LN2 5QY
England
London
SE13 6LH
England
Acre Street
Lindley
Huddersfield
HD3 3EA
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
12/03/2026: The following changes were made to the study record:
1. The key inclusion criteria were changed.
2. The key exclusion criteria were changed.
3. The Date of final enrolment was changed from 28/02/2026 to 30/09/2026
4. The study participating centres were updated.
5. The plain English summary was updated to reflect these changes.
01/11/2023: 2 public contacts were added.
19/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
