Dietary intervention in gestational diabetes

ISRCTN	ISRCTN65152174
DOI	https://doi.org/10.1186/ISRCTN65152174
IRAS number	242924
Secondary identifying numbers	CPMS 39156, IRAS 242924

Submission date: 10/02/2020
Registration date: 28/04/2020
Last edited: 20/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Gestational diabetes affects 35,000 pregnancies annually in the UK, causing adverse outcomes to mother and child, such as large-for-gestational age (LGA) (babies are born bigger than usual) and difficult deliveries. Obesity and excessive gestational weight gain are risk factors for gestational diabetes. However, it is unclear if weight gain remains important in women after diagnosis (28 weeks). National guidelines give no calorie or weight targets to guide management. Observational data suggests that women who avoid excessive weight gain during pregnancy, particularly after a diagnosis of gestational diabetes, had improved pregnancy outcomes, needed less medical intervention during labour and gave birth to infants with a healthier birth weight and had lower rates of LGA. Women with a reduced weight gain after diagnosis also had better postnatal glucose tolerance. This raises the exciting possibility that an 8-10 week intervention in late pregnancy could improve pregnancy outcomes and also reduce maternal diabetes risk long-term. The aim of this study is to assess the effects of a reduced-calorie diet in late pregnancy in women with gestational diabetes.

Who can participate?
Overweight or obese women with gestational diabetes

What does the study involve?
Participants are randomly allocated to receive diet boxes (standard calorie vs reduced calorie) containing all meals from 30 weeks to delivery. Food diaries, continuous glucose monitoring, Bluetooth scales and questionnaires will measure compliance, glucose control, weight changes and quality of life. Women will receive standard antenatal gestational diabetes care including regular ultrasound scans and treatment (insulin and/or metformin) as needed. The study will assess if an 8-10 week intervention can reduce maternal weight gain and infant birthweight. Delivery mode, treatment requirements, complications, and maternal glucose levels will also be assessed.

What are the possible benefits and risks of participating?
The information obtained from the study may help improve care for pregnant women with gestational diabetes in the future. Participants receive the best possible diet for women with gestational diabetes through the diet boxes, with minimal time for preparation or cooking (and, during the pandemic, also reduced exposure to shops). The provision of free food over 8 to 10 weeks saves participants' money. Blood test analysis may detect otherwise unknown abnormalities such as high cholesterol or longer-term risk of diabetes, offering the possibility of having important conditions diagnosed early. The risks of taking part in this study are low. The participants will be hungry on the diet (or feel very full). Some women may have a small weight loss during the study. There is good evidence that in women with gestational diabetes, weight loss can be safe and even beneficial to both mother and baby. Substantial weight loss can cause babies to be born smaller than usual (small-for-gestational-age). The researchers will monitor participants' weights carefully and stop the intervention and arrange appointments/ultrasound scans as needed. Giving blood samples may cause a small amount of discomfort. Wearing a glucose sensor could be inconvenient for some participants but most people do not find this troublesome. For participants consenting to have the DXA scan at Visit 4, there is a very small dose of radiation given. The dose of radiation received during a DXA scan is equivalent to the amount of natural atmospheric radiation received over a few hours and does not pose any substantial risk to participants.

Where is the study run from?
1. Cambridge University Hospitals NHS Foundation Trust (UK)
2. North West Anglia NHS Foundation Trust (UK)
3. Norfolk And Norwich University Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2018 to February 2023

Who is funding the study?
Diabetes UK

Who is the main contact?
Prof. Claire Meek
cm881@leicester.ac.uk

Contact information

Prof Claire Meek
Principal Investigator

Leicester Diabetes Centre
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

ORCID ID	0000-0002-4176-8329
Phone	+44 (0)7504 986426
Email	cm881@leicester.ac.uk

Study information

Study design	Randomized; Interventional; Design type: Treatment, Dietary
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	ISRCTN65152174_PIS_ v6_23Aug19.docx
Scientific title	DiGest: dietary intervention in gestational diabetes: a randomised controlled trial
Study acronym	DiGest
Study hypothesis	This study is a multicentre, prospective, randomised, controlled, double-blind trial to assess the effects of a reduced-calorie diet in late pregnancy in women with gestational diabetes.
Ethics approval(s)	Approved 16/07/2018, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8106; nrescommittee.westmidlands-blackcountry@nhs.net), REC ref: 18/WM/0191
Condition	Gestational diabetes
Intervention	This study design is a randomised controlled double-blind trial of a nutritional intervention. Overweight or obese women with gestational diabetes will be randomly allocated to receive either a standard-calorie or reduced-calorie dietbox every week from diagnosis of gestational diabetes until delivery. The study is double-blind as women and their research and clinical teams will not know which dietbox they will be receiving. This is a new way of running a nutritional study. Recruitment: At the time of referral for glucose (sugar) testing in pregnancy, obese and overweight women will receive an introductory flyer about the study. If gestational diabetes is diagnosed, women will be given a participant information leaflet and an opportunity to discuss study participation with their friends, family and the research team. Women who wish to participate in the study will give written informed consent and will be randomised before 30+6 weeks of pregnancy. Study visits: This study requires 4 study visits. Study visits will occur at enrolment (28-30 weeks) at 32 weeks and 36 weeks during pregnancy and at 6 weeks postpartum. The timeline for each participant is as follows: Study visit 1: (approximately 2 hours) The participant will have a further detailed explanation of the study, and the opportunity to ask any further questions about the study design or the dietboxes. Patients who agree to participate will then give written informed consent and will be enrolled into the study. At visit 1, the following procedures will be performed: • Consent form signed • Baseline weight, height and anthropometry - i.e. measuring the size of the body • Blood pressure • Fasting blood tests for sugar levels, hormones, blood count and cholesterol-related tests. Blood will also be stored for specialist tests (metabolomics, lipidomics and genetic testing) • Case report form will be completed, including information on pre-pregnancy weight, recent weight changes, normal dietary preferences, dietary requirements, medical and obstetric history and infant feeding intentions • 2 weeks’ masked continuous glucose monitoring will commence with detailed explanation to the participant (masked - the participant will not be able to see the readings). • 3 day food diary will commence • Urinalysis. A urine sample will be stored for specialist tests (microalbuminuria or metabolomic testing) • Participants will be given a Bluetooth set of scales on loan • Questionnaires will be completed: o Quality of Life (EuroQuol EQ5D) o Eating behaviour (three factor eating questionnaire; TFEQ-18) o Breastfeeding opinions and intentions • Women’s dietary preferences will be discussed and the first dietbox will be ordered for delivery to the participant’s home • Women will be randomised to receive either the standard calorie or reduced calorie dietbox • The first dietbox will be delivered 1-2 weeks after visit 1, to allow at least 7 days of baseline continuous glucose monitoring to be obtained Monitoring period: Participants will be in weekly telephone contact with the study team. Participants will weigh themselves regularly using the Bluetooth scales and the information will be assessed by the study team. The study team will also enquire about satisfaction with the dietboxes and adherence and will identify any issues which might arise. Participants will also attend their standard antenatal GDM appointments and will follow local hospital policies for monitoring. At their clinic appointments, participants will have: • Regular weight checks • Regular ultrasound scans for growth • Urinalysis If concerns are identified during the monitoring period, further study visits will be arranged by the research team. This might occur in the following circumstances: • Crossing down >20 percentiles on ultrasound assessment of estimated fetal weight • Participant has concerns about excessive hunger or other aspects of the diet • Participant or clinical team identify concerns about weight changes (+/- 5% weight change from pre-pregnancy weight) Study visit 2: 32 weeks’ gestation (45 minutes) The aim of this visit is to assess weight and to identify any issues with the dietboxes or food delivery. The following procedures will be performed at the 32-week visit: • Weight, anthropometry and blood pressure • 2 weeks’ masked continuous glucose monitoring will commence • 3-day food diary will commence to allow a detailed assessment of the continuous glucose monitoring data • Questionnaires will be completed: o Satisfaction with the dietbox o Quality of Life (EuroQuol EQ5D) o Breastfeeding opinions and intentions The participant will also be given the participant information leaflets about placental biopsy, cord blood collection, infant anthropometry (body size) examination and infant body composition assessment using the Peapod. Study visit 3: 36 weeks’ gestation (45 minutes) The aim of this visit is to collect information on glycaemia and weight at the end of the intervention period, but before labour has commenced. The study team will discuss with the participant the possibility of taking cord blood and placental tissue after labour, should appropriate facilities and staff be present at the time. Infant examination for anthropometry and body composition will also be discussed. These investigations are voluntary and a consent form will be signed at 36 weeks if the participant is willing to have these performed. The following procedures will be performed at the 36-week visit: • Weight, anthropometry and blood pressure • Fasting blood tests for sugar levels, hormones, blood count and cholesterol-related tests. Blood will also be stored for specialist testing (metabolomics, lipidomic and genetic testing) • 2 weeks’ masked continuous glucose monitoring will commence • 3-day food diary will commence • Questionnaires will be completed: o Satisfaction with the dietbox o Quality of Life (EuroQuol EQ5D) o Breastfeeding opinions and intentions Delivery Delivery modality and timing will be determined by local protocols in line with NICE guidance. Where possible, participants will be visited by the study team during their admission to allow the following procedures to be performed: • Sampling of placental tissue • Sampling of cord blood and amniotic fluid • Measurement of neonatal anthropometry • Measurement of neonatal body composition using a Peapod device These procedures may not be offered to all participants depending upon availability of equipment and staff at regional sites Study visit 4: 6 weeks’ postpartum (2 hours) Participants will return at 6 weeks’ postpartum for the last study visit. This visit will replace participants’ standard postnatal glucose (sugar) testing visit. The following procedures will be performed: • Weight and anthropometry (body size measurements) • DXA scan for body composition (at study sites where the relevant equipment and trained staff are available to do this) • Oral glucose tolerance test (OGTT) with blood testing in the fasting and postprandial state (0, 1 and 2 hours). This test is used to diagnose diabetes and involves having a sugary drink and blood testing before and afterwards. Blood will be tested to assess sugar levels, hormone levels and cholesterol. Some blood will be stored for more specialist tests (metabolomic, lipidomic or genetic testing) • Urinalysis; a urine sample will be stored for future batch analysis, for example, for microalbuminuria or metabolomic testing • Questionnaires will be completed: o Quality of Life (EuroQuol EQ5D) o Eating behaviour (three factor eating questionnaire; TFEQ-18) o Infant feeding choice will be documented
Intervention type	Behavioural
Primary outcome measure	Neonatal primary outcome measure: Standardised birth weight (standardised for infant gender and gestational age at delivery); Timepoint(s): birth/36 weeks gestation - from hospital data at V3 and birth Maternal primary outcome measure: Maternal weight change (28-36 weeks), measured using Seca scales at V1 and V3
Secondary outcome measures	Neonatal secondary outcome measures: 1. Large for gestational age (using local, national and international centiles and customised centiles) at birth 2. Small for gestational age (using local, national and international centiles and customised centiles) at birth 3. Cord blood C-peptide measured using Diasorin liaison method at birth 4. Cord blood glucose measured using Hexokinase method on Siemen's analyser at birth 5. Amniotic fluid glucose measured using Hexokinase method on Siemen's analyser at birth 6. Neonatal anthropometry (length, weight, abdominal circumference, head circumference, skinfold thickness, mid upper arm circumference) measured using tape measure, Seca scales, Holtain calipers at birth and V4 7. Neonatal body composition measured using Peapod device at birth/V4 8. Neonatal hypoglycaemia (defined as a low blood glucose requiring intravenous dextrose) from hospital data at V4 9. Neonatal admission to the neonatal intensive care unit (NICU) from hospital data at V4 10. Neonatal feeding type on discharge from hospital, from hospital data, maternal questionnaire at V4 11. Neonatal nasogastric feeding from hospital data at V4 12. Duration of neonatal admission from hospital data at V4 13. Neonatal jaundice requiring phototherapy from hospital data at V4 14. Preterm delivery from hospital data at birth 15. Estimated gestational age at birth from hospital data, dataset calculation at birth 16. Apgar scores from hospital data at birth Maternal secondary outcome measures: 1. Maternal weight and related measurements at 32 and 36 weeks and postpartum measured using Seca scales, Harpenden calipers, tape measure at V1, V2, V3 and V4 2. Maternal weight measured using Seca scales at V1, V2, V3 and V4 3. Maternal weight change (baseline to 32 weeks and 32 to 36 weeks) using dataset formula calculation at V3 4. Maternal BMI from dataset formula calculation at V1, V3 and V4 5. Maternal weight change (grams per week) from dataset formula calculation at V4 6. Velocity of maternal weight change (baseline to 32, 36 weeks and postpartum, and between each timepoint) from dataset formula calculation at V1, V2, V3, and V4 7. Maternal body composition at 6 weeks postpartum measured using DXA machine, Harpenden calipers, tape measure at V4 8. Maternal glycaemia on biochemical measurement (HbA1c and other biochemical measures of glycaemia) at 32 and 36 weeks and postpartum 9. Maternal glycaemia on continuous glucose monitoring at 32 and 36 weeks measured using Dexcom G6 CGM at V2 and V3: 9.1. Time in target (4.0 - 7.8 mmol/l) from Dexcom Clarity dataset at V1, V2, V3 and V4 9.2. Time below target (<4.0 mmol/l) from Dexcom Clarity dataset at V1, V2, V3 and V4 9.3. Time above target (>7.8 mmol/l) from Dexcom Clarity dataset at V1, V2, V3 and V4 9.4. Area under the curve for blood sugars >7.8 mmol/l from Dexcom Clarity dataset at V1, V2, V3 and V4 9.5. Area under the curve for blood sugars >6.7 mmol/l from Dexcom Clarity dataset at V1, V2, V3 and V4 9.6. Area under the curve for blood sugars <3.5 mmol/L from Dexcom Clarity dataset at V1, V2, V3 and V4 9.7. Area under the curve for blood sugars <2.8 mmol/L from Dexcom Clarity dataset at V1, V2, V3 and V4 9.8. Incidence of hypoglycaemic events from Dexcom Clarity dataset at V1, V2, V3 and V4 9.9. Mild-moderate episodes of hypoglycaemia <3.5mmol/l (mild) and <2.8 mmol/l (moderate) from data for area under the curve <3.5 mmol/l (mild) and <2.8 mmol/l (moderate) and duration of 20 minutes, from Dexcom Clarity dataset at V1, V2, V3 and V4 9.10. Nocturnal hypoglycaemia: glucose <3.5 mmol/l (mild) and <2.8 mmol/l (moderate) between 23.00-07.00 hours, from Dexcom Clarity dataset at V1, V2, V3 and V4 9.11. Time in hypoglycaemic range (<4 mmol/l; <2.5 mmol/l) from Dexcom Clarity dataset at V1, V2, V3 and V4 9.12. Peak and nadir blood glucose from Dexcom Clarity dataset at V1, V2, V3 and V4 9.13. Mean blood glucose from Dexcom Clarity dataset at V1, V2, V3 and V4 9.14. Mean nocturnal blood glucose from Dexcom Clarity dataset at V1, V2, V3 and V4 9.15. Mean postprandial blood glucose for 1, 2 & 4 hours after breakfast, lunch and dinner, from Dexcom Clarity dataset at V1, V2, V3 and V4 9.16. Standard deviation of blood glucose from Dexcom Clarity dataset at V1, V2, V3 and V4 9.17. Coefficient of variation of glucose measurements from Dexcom Clarity dataset at V1, V2, V3 and V4 9.18. Mean amplitude of glycemic excursions (MAGE) from Dexcom Clarity dataset at V1, V2, V3 and V4 10. Ultrasound measurements at baseline, 32 and 36 weeks, measured in absolute values and as a percentile and where relevant, as a categorical variable (<2.5th, <10th, >90th and >97.5th percentile): 10.1. Abdominal circumference (AC) from hospital data at V1, V2 and V3 10.2. Estimated fetal weight (EFW) from hospital data at V1, V2 and V3 10.3. Head circumference (HC) from hospital data at V1, V2 and V3 10.4. HC/AC ratio from hospital data at V1, V2 and V3 10.5. Umbilical artery flow studies from hospital data at V1, V2 and V3 10.6. Velocity of change of AC, HC, HC/AC and EFW from hospital data at V1, V2 and V3 10.7. Amniotic fluid index from hospital data at V1, V2 and V3 11. Cardiovascular variables at 32 and 36 weeks, and postpartum: 11.1. Blood pressure from Dinamap at V2, V3 and V4 11.2. Mean arterial pressure from Dinamap at V2, V3 and V4 11.3. Heart rate from Dinamap at V2, V3 and V4 11.4. Cardiac output from database formula calculation at V2, V3 and V4 12. Biochemical analysis of maternal blood at 32 and 36 weeks and 6 weeks postpartum: 12.1. Lipids including triglycerides measured using Siemens dimension methods 12.2. Insulin measured using Diasorin liaison method 12.3. Glucose measured using Siemens dimension hexokinase method 12.4. C-peptide measured using Diasorin liaison method 12.5. Liver function tests measured using Siemens dimension methods 12.6. Bile acids measured using Siemens dimension methods 12.7. C-reactive protein (including highly sensitive analyses) measured using Siemens dimension methods 12.8. Metabolomics using Metabolon Ltd or in house method using core facilities 12.9. Nutritional markers - Metabolon Ltd or in house method using core facilities 13. Indices of insulin production or beta-cell function - based on mathematical formulae in literature - for example Stumvoll index and Matsuda index, HOMA-B and HOMA-IR: 13.1. HOMA-IR and HOMA-B scores at 32 and 36 weeks and postpartum as per formulae in the literature 13.2. Matsuda scores (postpartum) - formula described in literature 13.3. Stumvoll index - formula described in literature 14. Maternal complications of pregnancy: 14.1. Pre-eclampsia from hospital data at V4 14.2. Polyhydramnios from hospital data at birth 14.3. Oligohydramnios from hospital data at birth 14.4. Threatened preterm labour from hospital data at birth 14.5. Antepartum haemorrhage from hospital data at birth 14.6. Postpartum haemorrhage from hospital data at V4 14.7. Cholestasis from hospital data at birth 14.8. Abnormal liver function tests in pregnancy from hospital data at birth 14.9. Infections from hospital data at V4 14.10. Maternal antenatal admissions from hospital data at birth 14.11. Pelvic girdle dysfunction from hospital data at birth 14.12. Carpal tunnel syndrome from hospital data at birth 14.13. Reduced fetal movements from hospital data at birth 14.14. Duration of maternal admission at delivery from hospital data at V4 15. Course of gestational diabetes: 15.1. Insulin required (type, dose, time of initiation) from hospital data at birth 15.2. Metformin required (dose, time of initiation) from hospital data at birth 15.3. Other medication required for glucose control from hospital data at birth 16. Delivery modality: 16.1. Delivery type from hospital data at birth 16.2. Timing of labour from hospital data at birth 16.3. Duration of labour from hospital data at birth 16.4. Induction of labour from hospital data at birth 16.5. Pharmacological treatment during induction, labour and delivery from hospital data at birth 16.6. Caesarean section rate from hospital data at birth 16.7. Elective vs emergency Caesarean sections from hospital data at birth 16.8. First vs repeat Caesarean sections from hospital data at birth 17. Maternal quality of life at 32 and 36 weeks and postpartum measured using EQ5D5K at V1, V3 and V4 17.1. Maternal mobility measured using EQ5D5K at V1, V3 and V4 17.2. Maternal self-care measured using EQ5D5K at V1, V3 and V4 17.3. Maternal usual activities measured using EQ5D5K at V1, V3 and V4 17.4. Maternal pain/discomfort measured using EQ5D5K at V1, V3 and V4 17.5. Maternal anxiety and depression measured using EQ5D5K at V1, V3 and V4 17.6. Maternal global health rating measured using EQ5D5K at V1, V3 and V4 17.7. Changes in quality of life measurements (baseline, 32, 36 weeks and 6 weeks postpartum) - database formula calculation 18. Maternal eating behaviour (baseline and postpartum) measured using TFEQ at V1, V3 and V4 18.1. Maternal hunger measured using TFEQ at V1, V3 and V4 18.2. Maternal emotional eating measured using TFEQ at V1, V3 and V4 18.3. Maternal uncontrolled eating measured using TFEQ at V1, V3 and V4 18.4. Maternal restraint measured using TFEQ at V1, V3 and V4 19. Food diary analysis at 32 and 36 weeks and 6 weeks postpartum: 19.1. Reported total calorie input from food diary analysis at V2, V3 and V4 19.2. Intake of carbohydrate, protein and fat (g and % of total) from food diary analysis at V2, V3 and V4 19.3. Glycaemic index of carbohydrate from food diary analysis at V2, V3 and V4 19.4. Saturated vs monounsaturated vs polyunsaturated fat from food diary analysis at V2, V3 and V4 19.5. Number of portions of fruit and vegetables eaten per day from food diary analysis at V2, V3 and V4 19.6. Dietary adherence - number, calorie content and nature of non-dietbox foods eaten at 32 and 36 weeks from food diary analysis at V2 and V3 19.7. Timing of non-adherence to dietboxes from food diary analysis at V2 and V3 19.8. Effects of non-adherence upon CGM measures of glycaemic control (including all the CGM measurements above) - database formula calculation at V2 and V3 19.9. Consistency between reported food intake and CGM glucose concentrations - database formula calculation at V2 and V3 20. Postpartum measurements: 20.1. Postpartum OGTT glucose concentrations and area under the curve from Dexcom Clarity database at V4 20.2. Postpartum maternal anthropometry (height, weight, waist circumference, hip circumference, skinfold thickness, mid upper arm circumference) measured using Seca scales, tape measure, Harpenden calipers at V4 20.3. Postpartum fat mass and fat-free mass measured using DXA machine at V4 21. Infant feeding choices at 6 weeks postpartum measured using maternal questionnaire at V4 22. Infant feeding behaviour measured using maternal questionnaire at V4 23. Additional safety-related analyses: 23.1. Small for gestational age (SGA) and intrauterine growth restriction (IUGR) from hospital data at birth 23.2. Adverse pregnancy outcomes: 23.2.1. Stillbirth from hospital data at birth 23.2.2. Neonatal death from hospital data at V4 23.2.3. Major congenital anomaly from hospital data at V4
Overall study start date	09/03/2018
Overall study end date	28/02/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	380
Total final enrolment	380
Participant inclusion criteria	1. Women with GDM diagnosed at 20 to 30+6 weeks’ gestation using a standard clinical 75g OGTT in accordance with the guidelines of the National Institute of Health and Care Excellence (NICE) 2. The NICE criteria state that the diagnosis of gestational diabetes will be made with one or more glucose concentrations during the OGTT of: 2.1. >5.6 mmol/l in the fasting state 2.2 >7.8 mmol/l 2 hours after 75 g glucose 3. Pre-pregnancy overweight or obesity (BMI >25 kg/m2) 4. A ultrasound-confirmed viable singleton pregnancy 5. Planned antenatal care at the same centre or a different study centre throughout their pregnancy (ie: not planning to move away from the region before delivery)
Participant exclusion criteria	1. Evidence of multiple pregnancy on ultrasound 2. Evidence of severe congenital anomaly on ultrasound 3. Patient planning to terminate the pregnancy for any reason 4. Significant pre-pregnancy diseases or comorbidities which increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (<1 year) 5. Significant complications in the current pregnancy, such as threatened preterm labour, severe anaemia (Hb<8g/dl) or intra-uterine growth restriction (IUGR) 6. Previous diagnosis of diabetes outside of pregnancy 7. HbA1c at baseline of >48 mmol/mol 8. Medications at the time of the OGTT which may interfere with the results of the OGTT (for example, steroids, immunosuppressants, certain antipsychotics) 9. Estimated fetal weight <10th percentile at diagnosis of GDM 10. Maternal requirement for a highly specialised diet (e.g. vegan) 11. Maternal severe food allergy, for example, a nut allergy causing anaphylaxis 12. Weight loss of >5% pre-pregnancy weight during pregnancy, prior to 28 weeks
Recruitment start date	01/11/2019
Recruitment end date	28/07/2023

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Cambridge University Hospitals NHS Foundation Trust

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

North West Anglia NHS Foundation Trust

Edith Cavell Hospital
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Kettering General Hospital NHS Foundation Trust

Rothwell Road
Kettering
NN16 8UZ
United Kingdom

East and North Hertfordshire NHS Trust

Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

The Princess Alexandra Hospital

Hamstel Road
Harlow
CM20 1QX
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

c/o Ms Ruth Holmes
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223217419
Email	ruth.holmes@addenbrookes.nhs.uk
Website	http://www.cuh.org.uk/
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Charity

Diabetes UK; Grant Codes: 17/0005712
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DIABETES UK LIMITED, British Diabetic Association
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	1. Peer-reviewed scientific journals 2. Conference presentation 3. Publication on website The researchers plan to publish, or have accepted for publication, the main study analysis within 1 year of the study end date. The protocol paper was accepted in March 2020.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version v6	23/08/2019	28/04/2020	No	Yes
Protocol file	version v9	26/11/2019	28/04/2020	No	No
HRA research summary			28/06/2023	No	No
Statistical Analysis Plan	version 2	18/11/2023	20/11/2023	No	No
Results article		19/02/2025	20/02/2025	Yes	No

Additional files

ISRCTN65152174_PROTOCOL_v9_26Nov19.docx: Uploaded 28/04/2020
ISRCTN65152174_PIS_ v6_23Aug19.docx: Uploaded 28/04/2020
ISRCTN65152174_SAP_v2_18Nov2023.pdf

Editorial Notes

20/02/2025: Publication reference added.
06/03/2024: The intention to publish date was changed from 28/02/2024 to 30/09/2024.
04/03/2024: Contact details updated.
22/11/2023: The recruitment end date has been changed from 31/12/2023 to 28/07/2023.
20/11/2023: The following changes have been made:
1. A statistical analysis plan (SAP) has been uploaded.
2. The total final enrolment has been added.
03/11/2023: The study participating centres Kettering General Hospital NHS Foundation Trust, East and North Hertfordshire NHS Trust, The Princess Alexandra Hospital NHS Trust were added.
23/08/2022: The intention to publish date has been changed from 28/02/2022 to 28/02/2024.
08/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 31/12/2023.
2. The overall end date was changed from 28/02/2023 to 28/02/2024.
3. The total final enrolment was changed from 500 to 380.
4. The plain English summary was updated to reflect these changes.
28/04/2020: Uploaded protocol Version 9, 26 November 2019 (not peer reviewed). The participant information sheet has been uploaded.
13/02/2020: Trial's existence confirmed by the NIHR.