Type 1 Diabetes Prevention /Immunology

Investigator:

Mark Evans, [email protected] (UK Study coordinator)

Summary:

INNODIA is an international consortium with academic institutions, healthcare teams, scientific and industrial partners, and patient organisations which have joined forces to significantly improve the understanding of type 1 Diabetes and to pave the way to novel therapeutic options to prevent and cure this disease.

Aim: To develop a European infrastructure for the recruitment, detailed clinical measurements and samples of a large group of newly diagnosed patients with type 1 diabetes (T1D) and unaffected family members (UFM), generating an unrivalled resource for T1D discovery science.

Further Information: https://www.innodia.eu/

Updated Oct 2021

Investigator:

Dr Yuk-Fun Liu

Beth Thorne, [email protected]

Summary:

TrialNet is an international network of leading academic institutions, physicians, scientists and healthcare teams dedicated to the prevention of type 1 diabetes.

To identify by offering risk screening and maintain a pool of people who may be eligible for entry into prevention trials, as these become available.

Further Information: https://www.trialnet.org

Updated Oct 2021

Investigator:

Proffessor John Todd

Summary:

The purpose of this trial is to assess the safety, tolerability and optimal dose of Proleukin in children and adolescents with type 1 diabetes, through study of the effects on the immune system and metabolic parameters. Note this trial was originally called DILTY

Further Information: https://www.octru.ox.ac.uk/trials/trials-in-set-up/itad

Updated Oct 2021

Investigator:

Professor Colin Dayan, [email protected]

Summary:

This is a double blind Phase 2 study to assess the safety and efficacy of Ustekinemab in children & adolescents aged 12 with new onset T1D. Participants will be given S/C Ustekinemab at weeks 0, 4, and 12 & every 8 weeks for 1 year. There will be 8 study visits over 1 year, 3 of which will be at home. Mixed meal tolerance tests will be performed at 0, 26 and 52 weeks. All participants will be offered CGMS using the Freestyle Librae system. An information video will be available at www.type1diabetesresearch.org.uk

Tracking of Risk for diabetic nephropathy and cardiovascular disease in young people with type 1 diabetes recruited to the AdDIT Study

Investigator:

Dr Loredana Marcovecchio

Summary:

The AdDIT follow up study, is following up the AdDIT cohort to collect data to see if more relevant effects, such as those on direct manifestations of cardiovascular disease (CVD), renal and retinal disease, are most likely to become apparent in the longer term, during early adult life. Thus, long-term follow-up of the whole AdDIT cohort will allow the characterisation of rates of vascular complications during early adulthood reflecting a potential ‘metabolic memory’ of glycaemic and non-glycaemic exposures as well as treatment effects during pubertal years.

Further Information: www.addit-trial.org

Updated Oct 2021

Investigator:

Professor Emile Hendriks, [email protected], Professor Loredana Marcovechio, [email protected] (UK study coordinator)

Summary:

Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D).
Clinicaltrials.gov Number: NCT04509791, https://clinicaltrials.gov/ct2/show/NCT04509791
EudraCT Number: 2019-003265-17 https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003265-17/BE
Aim: The drug ATG (Anti Thymocyte Globulin) will be tested over 12 months in adolescents to adults (12-25 years for now, soon to be followed by 5 to 25 years, n=114). ATG, given once in a two days infusion regimen, is a drug recently shown to be able to keep the balance between attacking and regulating cells within the immune system, and thereby helping to preserve insulin secretion. Defining the minimal effective dose of ATG treatment is one aim of the study.

Further Information: https://www.innodia.eu/trials/meld-atg/ www.addit-trial.org

Updated Oct 2021