C-peptide Clinic Screening

• Research type

  Research Study

• Full title

  C-peptide screening in a Secondary Care Type 1 Diabetes Clinic

• IRAS ID

  310132

• Contact name

  Christopher Redford

• Contact email

  christopher.redford@nhs.net

• Sponsor organisation

  Torbay and South Devon NHS Foundation Trust

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  To more accurately classify patients within the Type 1 Diabetes service at Torbay Hospital. The use of c-peptide measurement is a well-recognised tool for distinguishing patients with Type 1 Diabetes from those with other forms of diabetes such as Type 2 Diabetes or Monogenic Diabetes. Measurement of c-peptide in all patients diagnosed with Type 1 Diabetes, for more than 3 years, will allow more accurate classification and subsequently more appropriate treatment strategies and patient education.
  Historically, differentiating Type 1 Diabetes from other forms of Diabetes had been viewed as less important due to the limited treatment options for diabetes in general. The traditional pathway generally culminated in insulin treatment, which is both expensive and laborious for patients. However, over the past 10 years, new drug classes (GLP 1 Agonists and SGLT2 inhibitors) have revolutionised the care of Type 2 Diabetes with improvements in glycaemic control and Cardiovascular endpoints. There is also increasing accessibility to technologies for supporting Type 1 Diabetes care (Flash Glucose monitoring, Continuous Glucose monitoring, Insulin pumps), however these remain expensive with proven benefit largely lying only in patients with true Type 1 Diabetes. Therefore, distinguishing the pathophysiology underlying the patient’s diabetes, be that insulin deficiency in Type 1 Diabetes or Insulin Resistance in Type 2 Diabetes, has become increasingly important to deliver tailored, and evidence based, care

  Historical research suggests that using traditional markers (BMI, Age, Family History, Presentation, Presence of Ketones at diagnosis) to distinguish Diabetes Type is inaccurate and prone to bias. There has been a lot of recent attention around the use of c-peptide as a diagnostic tool. Current research suggests the using c-peptide, after 3-5 years of diabetes, is a highly accurate way of classifying diabetes type, as well as a potential marker of response to different therapies. Large scale clinical trials, such as ‘StartRight’, have used c-peptide as a reliable tool to support correct classification at diagnosis of diabetes. However, the use of c-peptide in patients with established diabetes to reclassify, and potentially modify treatment pathways, is innovative and to this point largely limited to large research centres. Currently, there is no mention of c-peptide use in NICE diabetes guidance and its use locally has been limited to patients with atypical presentations, or response to treatment. However, there is growing evidence that using c-peptide screening is a cost-effective tool in the diagnosis and management of Type 1 Diabetes. Such an approach remains well outside of routine clinical practice and this project would gauge the feasibility and cost effectiveness of its use within a district general hospital. The outcomes of this project may generate evidence to support the wider use of such screening, as part of NICE guidance.
  

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  22/YH/0033

• Date of REC Opinion

  18 Feb 2022

• REC opinion

  Favourable Opinion