CLASP pilot study

• Research type

  Research Study

• Full title

  Safety and feasibility of insulin simplification or cessation in frail older adults with type 2 diabetes: a pilot study of CLASP (using C-peptide to clarify, simplify and personalise type 2 diabetes management in frail older adults)

• IRAS ID

  328591

• Contact name

  Ewan Pearson

• Contact email

  e.z.pearson@dundee.ac.uk

• Sponsor organisation

  University of Dundee

• Duration of Study in the UK

  2 years, 0 months, 29 days

• Research summary

  Approximately 10% of people with type 2 diabetes (T2D) in Scotland are receiving insulin treatment. While insulin helps with blood sugar, it can also cause very low blood sugar levels and adds to treatment burden because it is a medicine requiring frequent injections and dose adjustments. This may affect patients’ quality of life. This can make it difficult for older and frail patients to manage. People with T2D may still be able to produce their own insulin even if someone has had T2D for many years. Although doctors stop insulin in patients who no longer require it, there is not a standardised approach. We hope to identify these people with T2D who are still producing insulin using a blood test and simplify their treatment by stopping or reducing insulin using an approach created by the study team.
  We will first conduct a pilot study to test the safety and feasibility of stopping or reducing insulin injections in older people. We will use a medication called GLP1-receptor agonist as a substitute for insulin. It can be given as a once-weekly injection or tablet. It has been used as a treatment for T2D for many years. This treatment has less risk of causing low blood sugar and may be safer for older patients as a result. We will use a sensor called continuous glucose monitoring (CGM) to monitor participants’ blood sugar levels to make sure it is safe. We will record episodes of hospitalisation for issues related to diabetes management and other outcomes to make sure stopping or reducing insulin is safe. We will assess the acceptability of the change to the patient and the deliverability of the intervention. We will also test the use of patient completed questionnaires which are used to assess how patients coped with the change in treatment.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  23/ES/0031

• Date of REC Opinion

  14 Sep 2023

• REC opinion

  Further Information Favourable Opinion