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Current trials

JDRF-funded researchers are carrying out clinical research projects all around the world. They are reliant on people volunteering their time to help test ideas and make new discoveries. 

Researchers will work with people of different ages and backgrounds and sometimes they look for a specific medical history. They might even need people who do not even have type 1 diabetes. Follow the links below to learn about current trials that need volunteers.

Continuous glucose monitoring in women with type 1 diabetes in pregnancy trial (CONCEPTT)

What is the project trying to achieve? 

Poor glucose control during pregnancy can give rise to complications for both the mother and infant. For example, preeclampsia (high blood pressure and protein in the urine after the 20th week of pregnancy) and preterm birth are much more common in women with type 1, and the infants are at higher risk of developing type 2 diabetes and chronic illnesses as adults.

This international study, led by Canadian investigators, will test: 1) whether CGM use during pregnancy can improve glucose control and reduce the likelihood of complications and 2) whether CGM use in women planning pregnancy will improve glucose control to make pregnancy more likely, and as well as reducing the risk of complications. 

What are volunteers required to do?   

Eligible women will either use a CGM along with their standard insulin regimen, or continue on their standard insulin regimen without a CGM.

Who can take part? 

To be eligible to take part, you need to be a woman aged between 18 and 40 years, to have had type 1 for more than 12 months, and to be using either a pump or insulin injections (minimum 3 times a day). Those recruited to the group for pregnant women should have been pregnant for 13 weeks or less, and be carrying only one child (i.e. not twins). Those recruited to the pre-pregnancy group should be planning to become pregnant and looking to optimise their glucose control beforehand.

Where is the study being conducted? 

The centre in Cambridge is currently recruiting, while centres in Ipswich, Norwich and London will begin accepting participants soon.

Contact details

Dr Helen Murphy
Addenbrooke's Hospital
Metabolic Research Laboratories
Level 4, Institute of Metabolic Science
Box 289

01223 769079
hm386@medschl.cam.ac.uk

Estrogen in Type 1 Diabetes (EsTiD) study

What is the project trying to achieve?

Young people with type 1 tend to have lower blood levels of the hormone IGF-I than people who do not have diabetes. This is associated with difficulties in controlling blood sugar levels and it has been linked to the risk of developing complications.

Women who take the oral contraceptive pill have similar changes in their level of IGF-I as women with type 1. The pill contains two sorts of hormones but the effect on IGF-I is from oestrogen. Oestrogen seems only to affect IGF-I levels when it is taken by mouth, but not when it is made naturally by the body or when it is given as a patch. This study looks at the effect of estrogen from a tablet and a patch on IGF-I in young women with type 1.

Who can take part? 

The researchers are currently recruiting women aged between 16-35 who have had type 1 for over a year

Contact details

For information contact Dr Burak Salgin on 07561 177 941 or bs273@medschl.cam.ac.uk

Can interleukin-2 stop further damage to the pancreas in type 1 diabetes? (DILT1D study)

What is the project trying to achieve?

This research study is investigating a new medication for type 1 diabetes, using a drug called aldesleukin (interleukin-2).  The research team are investigating whether this medication can halt the damage to the pancreas of the people with newly diagnosed type 1 diabetes and if so, what dose of the drug is required for the best results.

Who can take part?

The team are currently recruiting people aged 18-50 who have been diagnosed with type 1 in the past two years.

Contact Details

For more details contact Dr Frank Waldron-Lynch and team at the University of Cambridge.

www.clinical-trials-type1-diabetes.com

Email: DILT1D@cimr.cam.ac.uk

Tel: 01223 762327

Text: DILT1D to 82727

Continuous glucose monitoring user survey

What is the project trying to achieve?

Professor John Pickup from King's College London, a pioneer in the development of insulin pump therapy, wants to hear about users' experiences with continuous glucose monitors (CGM).

Who can take part?

Anybody with type 1 diabetes who uses a CGM on a 24/7 basis (or almost) or their carers.

What are volunteers required to do?

Particpants can get involved by answering the questions in this survey  http://www.surveymonkey.com/s/B8TPZ9D

Contact Details

For more information email cgm2013uk@gmail.com 

Reducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes - REMOVAL

What is the project trying to achieve?

The trial is designed to test whether the drug metformin, when combined with insulin therapy, is effective in preventing or reducing the elevated risk of cardiovascular disease associated with diabetes.

What are volunteers required to do?

To be eligible for the REMOVAL study, you must be at least 40 years old, have T1D, and have either previously experienced a blood vessel complication or have risk factors for a blood vessel complications. If you decide to join the trial you will be asked to take a daily pill. This may be either metformin or a placebo. It is a three-year study, so you will have additional monitoring tests at your clinic visits while you are taking part in the study.

Where is the study being conducted?

The following hospitals in the UK are participating in the study:

  • Stobhill Hospital, Glasgow
  • Ninewells Hospital, Dundee
  • Diabetes Clinical Research Centre, Plymouth
  • Royal Devon and Exeter NHS Foundation Trust, Exeter
  • Royal Victoria Hospital, Newcastle
  • University Hospital of North Durham, Durham
  • Manchester Royal Infirmary, Manchester
  • Michael White Centre for Diabetes, Hull Royal Infirmary
  • University Hospital, Liverpool
  • International Centre for Circulatory Health, Imperial College Healthcare NHS Trust, London

Sites in the Netherlands, Denmark Canada and Australia are also recruiting patients to the study.

Contact details

For further details please visit: http://1.usa.gov/tSfXi0

Developing corneal confocal microscopy for human diabetic neuropathy

What is the project trying to achieve? 

This project is trying to develop a new automated and non-invasive eye test to assess for nerve damage in diabetic patients. At the moment this is assessed using relatively crude tests which miss early nerve damage and the more sensitive tests need to remove skin in the form of a biopsy to assess under a microscope. We are studying patients with Type 1 diabetes with short duration of diabetes (<10 yrs) but also patients with diabetes for over 50 years to try and assess which factors might protect these patients from developing major complications of diabetes as well as patients with impaired glucose tolerance who are yet to develop diabetes.

What are volunteers required to do?

We will undertake detailed testing of the nerves using the standard tests of neurophysiology, but in addition we will use our ophthalmic instrument called the corneal confocal microscope to try and see if the corneal test is as good if not better than the standard tests. The groups of patients we are studying include patients with Type 1 diabetes and in particular patients with diabetes for more than 50 years of diabetes. These patients will also have an assessment of proteins and metabolites in their blood and will undergo genetic assessment.

For further details please contact:

Professor R A Malik Rayaz.a.malik@man.ac.uk Tel. 0161 275 1196

A longitudinal study of ophthalmic markers of neuropathy in Type 1 diabetes

What is the project trying to achieve?

This project is assessing the development and progression of neuropathy in patients with Type 1 diabetes. We are studying patients with Type 1 diabetes, Latent autoimmune diabetes of adults (LADA) and Type 1 diabetic patients with a >50 yrs of diabetes on an annual basis over 4 years.

What are volunteers required to do?

We will undertake detailed testing of the nerves using the standard tests of neurophysiology, but in addition we will use our ophthalmic instrument called the corneal confocal microscope to try and see if the corneal test is as good if not better than the standard tests.

For further details please contact 

Professor R A Malik Rayaz.a.malik@man.ac.uk Tel. 0161 275 1196

Nephropathy Family Study (NFS) and Adolescent Type 1 Diabetes Cardio Renal Intervention trial (AdDIT)

What is the project trying to achieve? 

NFS aims to explore the link between protein in the urine of young people with diabetes (age 10 – 16 yrs) and blood pressure, blood fats and urinary protein in their parents.

AdDIT is a study looking at the effects of drugs which lower the blood pressure or blood fats.

What are volunteers required to do?

Volunteers are asked to provide two sets of urine samples to test for protein and at their annual clinic review they will be asked for some extra blood for checking HbAIc. Volunteers in NFS may be invited to join AdDIT or if they do not wish to do so they will be followed up in NFS.

Contact details

Screening is taking place in these regions of the UK:

Aylesbury and High Wycombe lisatate@nhs.net
Birmingham rebecca.morgan@bch.nhs.uk
Birmingham (Heartlands) Indy.Birak@bch.nhs.uk
Bristol theresa.portch@bristol.ac.uk
Bolton Jessica.Nichols@cmft.nhs.uk
Cambridge ja453@medschl.cam.ac.uk
Ipswich jon.hassler-hurst@ipswichhospital.nhs.uk
Manchester Elizabeth.Jacklin@cmft.nhs.uk
sue.greenhalgh@salford.nhs.uk
Newcastle and 
Middlesborough
alison.murray@stees.nhs.uk
joanne.lawson5@nuth.nhs.uk
Northampton lucy.dudgeon@ngh.nhs.uk
Norwich Joe.ellis-gage@nnuh.nhs.uk
Oxford susan.rous@orh.nhs.uk
Reading juliesutton@nhs.net
Stockport

sara.bennett@stockport.nhs.uk

Wigan Jamie.Dolan@wwuh.nhs.uk
West Suffolk jennie.sharp@wsh.nhs.uk

or email the coordinating centre: ukgrid@paed.cam.ac.uk

Type 1 Diabetes TrialNet

What is the project trying to achieve?

The goal of TrialNet in the UK is to perform intervention studies to preserve insulin-producing cells in individuals at risk for type 1 diabetes. TrialNet will focus on identifying individuals "at risk" for developing type 1 diabetes. Risk is based on having autoantibodies or other markers and results of certain tests. These tests include Oral and Intravenous Glucose Tolerance Tests.

TrialNet is screening relatives of people with type 1 diabetes to find out if these family members are "at risk" for developing type 1 diabetes.

What are volunteers required to do?

Screening involves a simple blood test to look for diabetes-related autoantibodies that may appear years before type 1 diabetes develops.  If the right combination of autoantibodies is present the participant may be eligible to continue into the intervention study (TrialNet Oral Insulin Study).

The intervention study requires a capsule containing crystalline insulin to be taken daily.  The participant needs to have clinic visits for fasting blood tests on a six monthly basis.

Participants who are ineligible for the intervention study but have autoantibodies present will be followed up on a 6 monthly basis in the TrialNet Natural History study.  If an alternative intervention study becomes available in TrialNet they will be offered a place on this (if eligible).

Research Nurses: Harriet Castleden, Ann Morgan

Contact details

TrialNet Team
Diabetes and Metabolism
Learning and Research
Southmead Hospital
Bristol BS10 5NB

Tel: 0117 323 8736/7
trialnet-uk@bristol.ac.uk

Pre-Point Study

What is the project trying to achieve? 

The aim of this international study is to test oral insulin to see if it could delay or prevent the onset of diabetes in children who are at very high risk of developing diabetes. Pre-Point is a pilot study to decide on the best dose to use for a larger, definitive trial.

What are volunteers required to do? 

The study is open to children aged between 18 months and 7 years who do not have Type 1 diabetes but have at least two 1st degree family members (parent(s) or sibling(s)) with Type 1 Diabetes or an identical twin with Type 1 diabetes.

Before study entry the child will be screened to check if they are eligible.  This initially involves taking a mouth swab for DNA testing. If results show the child is in the high risk genetic group they will then be offered a blood test to check for pancreatic autoantibodies. If the autoantibodies result is negative, the child can be enrolled into the Pre-Point study.  They will be asked to take oral insulin daily for 3 -18 months and attend clinic visits every 6 months. If the autoantibodies result is positive the child may be eligible for other prevention studies but this will be discussed with the parents at that time.

Contact details

Polly Bingley 
Tel: 0117 323 6188 
Email: polly.bingley@bristol.ac.uk
www.diabetes-point.org

Phase 1b Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes (MonoPepT1De-1b)

What is the project trying to achieve? 

We are studying whether a new type of treatment that uses a fragment of a protein from the insulin making cells (proinsulin) can be used to stop the autoimmune process that destroys these cells in type 1 diabetes. The new approach is called “peptide immunotherapy” and has been termed a kind of “Diabetes Vaccine”.  In this early phase study, we are mainly checking that the treatment is a safe. This is the second study with this treatment and the first study showed no significant side effects other than redness at the site of injection.

What are volunteers required to do?   

Before entering the trial, we will do blood tests to check that you do have type 1 diabetes, that your body still makes some insulin, that you have the right type of immune system for this treatment and that you are healthy in all other ways.  After entering the trial, you will have 12 treatments with a very small injection under the skin of your arm at 2 weekly intervals and then be followed up for a further 6 months (12 months in all). Overall there will be 15 visits to the research centre. After each treatment you will need to stay for about an hour for observations and during this time we will also give advice and help on blood sugar control and ask you to complete some questionnaires. There will also be three longer visits (3 hours) when we check the how much insulin your own body can make after drinking a build-up meal drink. The study visits can be timed for your convenience to some degree.

Who can take part? 

You need to be aged between 18 and 40 years and have very recently been diagnosed with type 1 diabetes (the first treatment needs to be given within 100 days of the date of diagnosis).

Where is the study being conducted? 

There will be study centres in Cardiff, Bristol, London (Guy’s Hospital) and Newcastle.

Contact details

Julie Pell, Trials Coordinator, Centre for Endocrine and Diabetes Science, Cardiff University School of Medicine, Heath Park, Cardiff CF14 4XN.  PellJC@cardiff.ac.uk 

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