Pain Alleviation In diabetic Neuropathy using hybrid cLosEd Loop inSulin pumpS: the PAINLESS study
Type 1 diabetes
PAINLESS is a two-centre randomized cross-over feasibility study with blinded outcome assessment of patients with painful diabetic neuropathy (defined as pain severity of ≥4 on an 11-point numerical rating scale [NRS] measuring 24-hour pain scores [0 to 10] averaged over the last 7 days). The intervention is hybrid closed loop (HCL) and continuous glucose monitoring (CGM), versus standard care (including CGM). More than 99% of people living with type 1 diabetes in the UK currently have access to continuous glucose monitoring, and this would serve as a usual care control. The research team collecting/analysing study outcomes will be blinded to treatment allocation. Randomisation will be performed using a secure online randomisation programme (https://www.sealedenvelope.com/simple-randomiser/v1/lists), thereby ensuring allocation concealment. Participants will be randomised at the level of the individual in a 1:1 ratio to either Treatment Sequence A (HCL+CGM followed by CGM only) or Treatment Sequence B (CGM only followed by HCL+CGM). The randomisation will use a minimisation algorithm to ensure balance in the treatment allocation, taking into account centre, age (18-39, 40-59, 60+ years), gender at birth and ethnicity (White, Asian/Asian British, Black/African/Caribbean/Black British, Other ethnic group). After potential participants are identified, they will be invited to a 2-hour screening visit. At this visit, questions on the study will be answered, and if willing, the participants will give written informed consent. A medical history and examination will be performed, including pain medication history, baseline questionnaires and baseline neurophysiological assessments. An HbA1c will be taken if unavailable from the last 3 months. After this, participants will enter a 4-week baseline data collection, where they will be given a Dexcom G7 for continuous glucose monitoring and a SmartWatch which will analyse physical activity and sleep, and will be asked to comp
1. Clinical diagnosis of type 1 diabetes for at least 5 years (commenced on insulin treatment within 1 year of diagnosis) 2. Daily neuropathic pain for at least 3 months 3. Distal symmetrical polyneuropathy confirmed by the Toronto Clinical Neuropathy Score >5 4. 24-hr average pain score >4 (BPI-MSF) 5. HbA1c between 6.5 and 13% 6. On stable neuropathic pain medications for the past 3 months 7. Mean total pain intensity of at least 4 on an 11-point numeric rating scale (NRS; with 0 being ‘no pain’ and 10 ‘worst pain imaginable’) during the last week of the screening period 8. Willing and able to comply with the study schedule and be available for the treatment duration 9. Able to give written informed consent
1. Non-diabetic neuropathies 2. Other chronic pain disorders are more severe than painful diabetic neuropathy 3. History of major psychiatric disorders 4. Pregnancy/breastfeeding or planning pregnancy during the course of the study 5. Hearing or visual impairment, which would impede the ability to use the technological interventions (as per PI discretion)