Pilot study on effects of CGM in children and adolescents with T1DM
Research type
Research Study
Full title
Pilot Study on the Effects of Continuous Glucose Monitoring on Sleep Quality and Glycaemic Control in Children and Adolescents with Type 1 Diabetes, and their Parents/Carers
IRAS ID
223333
Contact name
Nikki Davis
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
In Type 1 Diabetes (T1D), good control of blood sugar (glucose) levels (BGLs) is essential in reducing risk of complications of diabetes. Usually, people with diabetes use a finger-prick blood sample and blood glucose meter - standard monitoring of blood glucose (SMBG). This method provides the BGL at the time of sampling. Whilst accurate, it is difficult to detect variations in BGLs using SMBG. Additionally, the multiple daily finger-pricks is often painful and uncomfortable for patients.
Continuous glucose monitoring (CGM) is a sensor that measures interstitial fluid glucose levels (interstitial fluid is the fluid surrounding the body’s cells). This method can identify BGL trends and variations. However, interstitial fluid glucose levels lag behind BGLs. This lag is unimportant with relatively stable BGLs. However, when BGLs are rapidly changing, they may appear normal using CGM, even if they are not normal. Therefore, it is not straightforward to say whether CGM will reduce low BGLs. However, this method requires no finger-pricks.
Studies have compared the effects of CGM and SMBG in T1D. Most studies show improved BGL control with both methods, but greater improvement in CGM users. No substantial difference has been demonstrated regarding risk of severely low BGLs or quality of life (QOL). There is limited evidence for the effectiveness of CGM, particularly in children.
Additionally, the relationship between CGM use in T1D and sleep has not been frequently investigated. Sleep is an important outcome. Research shows fragmented sleep is associated with poor BGL control and QOL. Poor sleep quality in children often has a direct impact on the sleep quality of parents/carers.
Our pilot study will explore child and parental sleep quality, frequency of low BGLs and diabetes control in children and young people with T1D in Southampton before and during the use of CGM.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0161
Date of REC Opinion
4 May 2017
REC opinion
Further Information Favourable Opinion