CANGLUVIT Pilot Study V1.1
Research type
Research Study
Full title
Cardiac Autonomic Neuropathy and GLUcose Variability In Type 1 diabetes (CANGLUVIT)- pilot study
IRAS ID
345976
Contact name
R Tan
Contact email
Sponsor organisation
King's College Hospital
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
People with type 1 diabetes mellitus (T1D) risk developing damage to nerves (neuropathy) due to chronic high blood glucose levels. Cardiac autonomic neuropathy (CAN) is caused by damage to the nerves controlling the heart and blood pressure. It causes a fast-resting heart rate and symptoms such as dizziness, light headedness, and weakness on standing. People often present with advanced disease and disabling symptoms. Importantly, it’s presence increases the risk of death 5-fold. It remains understudied with the prevalence (number of people affected) remaining largely unknown.
Around 25% of people with T1D have an eating disorder or disordered eating (T1DE). They are at increased risk of complications due to poor glucose control. Despite this, there are no studies investigating CAN within this group.
This cross-sectional pilot study aims to test the feasibility of screening and testing for CAN in 20 people with T1DE compared to 20 people with T1D. The secondary objectives are to identify any association between CAN and glucose variability (how much a persons glucose changes during a day) and measures of quality of life and mental health.
All participants will undergo cardiac autonomic function testing and complete 6 questionnaires assessing parameters of mental health, disordered eating, autonomic neuropathy symptoms and overall quality of life. Blood tests will be taken to assess HbA1c and exclude other possible causes of neuropathy. All participants will currently be using continuous glucose monitoring (CGM) sensors as part of routine care. Data from their CGM will be downloaded to assess markers of glucose control such as glycaemic variability (%CV) and Time in Range (TIR).
Results from the study will assess feasibility of CAN testing within the T1DE cohort. Future larger studies based on this study will be important in identifying the prevalence of CAN and help develop guidelines for screening and management.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0117
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion