Sleep T2D

SLEEP T2D is a feasibility and observational cohort study with a subset of participants included in an RCT of a CE marked medical device used within its intended purpose.

The RCT is a randomised controlled parallel arm trial where participants will be randomised in a 1:1 ratio to CPAP or no CPAP. 140 participants will be randomised.

The primary aim of SLEEP T2D is to assess the feasibility of running a substantive RCT in patients with T2D, randomising participants between CPAP and no CPAP.

The aim of such a substantive RCT would be to determine the impact of OSA treatment (CPAP vs no CPAP) on the progression of diabetic nephropathy/CKD in patients with T2D. The proposed clinical primary outcome would be eGFR as measured by serum creatinine levels.

Suitable patients will be identified at NHS Trusts across the country.

Adult patients with Type 2 diabetes, no diagnosis of obstructive sleep apnoea, and an eGFR equal to or more than 15.

Participants in the randomised controlled trial arm will be randomised between two years of treatment with CPAP or no treatment.

There are a large number of objectives, as this is a feasibility study:

Primary objectives

1. To assess willingness of participants to be randomised
2. To assess willingness of clinicians to recruit participants
3. To assess follow-up rates and adherence/compliance rates
4. To provide data to inform the sample size for a substantive trial
5. To optimise the choice of outcome measures for a substantive trial

Secondary objectives

1. To assess the impact of OSA treatment (CPAP) in patients with T2D on:
2. Measures of diabetic nephropathy and chronic kidney disease including eGFR, Cystatin-C, and albumin/creatinine ratio
3. Diabetic neuropathy (including peripheral painless and painful peripheral neuropathy, cardiac autonomic neuropathy and peripheral autonomic neuropathy)
4. Diabetic retinopathy and maculopathy
5. Metabolic parameters such as weight, HbA1c, BP, and lipids profile

Tertiary objectives

1. To explore the utility of different biomarkers in screening for OSA in patients with T2D
2. To explore the mechanisms via which CPAP might have an impact on diabetes-related complications
3. To assess the relationship between other sleep-related disorders, such as sleep duration, sleep quality and sleeping patterns and metabolic parameters and vascular disease in patients with T2D
4. To build up a cohort of well characterised patients for longitudinal follow up to inform us about the natural history of OSA, sleep-related disorders, and diabetes-related complications