Renal failure Urological and Genital Diseases Renal failure
Conditions
Interventions
Interventions as of 29/12/2016:
Patients who routinely receive either in-centre haemodialysis or home haemodialysis will be enrolled and require a total of 3 visits. The first will be
over this time they will be asked to complete the provided diary. The third visits will be remove the sensor, collect the diary and re-download the SMBG data. They will they complete a validated quest
so have the sensor on and observational period over 14 days undertaken twice.
There will be no other direct follow up from this study protocol, however all participants will receive a
Sponsors
Portsmouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female aged 18 years or above 2. Diagnosis of Diabetes Mellitus requiring insulin therapy 3. On Renal Replacement Therapy for a minimum of 3 months 4. Have downloadable SGBM devise already in use
Exclusion criteria
Exclusion criteria: 1. Acute prescription (within 2 weeks) of medication that may increase or decrease serum glucose 2. Planned change of renal replacement modality during study period 3. Co-enrolment in other studies that provided therapies or interventions that may affect glycaemia control 4. Unable to provide informed consent Added 29/12/2016: 5. Planned x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI) or high-frequency electrical heat (diathermy) treatment during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 29/12/2016: Ambulatory glucose profile as generated by 14 days of interstitial glucose monitoring. Original primary outcome measure: Overall glycaemic variability is determined using interstitial glucose measurements collected by a continuous glucose monitor over a 14 day period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 30/12/2016: 1. Analysis of the ambulatory glucose profile during day-time hours, night-time hours, pre-meal period, postprandial period, pre-dialysis (6 hour window), post-dialysis (6 hour window and 12 hour window) and hour by hour across the day 2. Analysis of the area under the curve of the ambulatory glucose profile spent hypoglycaemic (10mmol/l and >15mmol/l) 3. Analysis of discrete episodes of the ambulatory glucose profile hypoglycaemic (10mmol/l and >15mmol/l) 4. Score from Stanford patient education centre questionnaire at sensor removal 5. Relationship between dialysis prescriptions and insulin regimes to the overall glycaemic variability is determined using interstitial glucose measurements collected by a continuous glucose monitor over a 14 day period 6. Relationship between glycaemic variability and demographic data (details of past medical, socioeconomic and educational history) is determined through interstitial glucose measurements collected by a continuous glucose monitor over a 14 day period and participant interviews Original secondary outcome measures: The following secondary outcomes are measured during 14 day continuous glucose monitoring 1. Time during 14 day continuous glucose monitoring spent within glucose target range (4-10mmol/L) 2. Time during 14 day continuous glucose monitoring spent above target range > 10mmol/L 3. During 14 day continuous glucose monitoring number of discrete episodes > 10mmol/L 4. Time during 14 day continuous glucose monitoring spent above target range > 15mmol/L 5. During 14 day continuous glucose monitoring number of discrete episodes > 15mmol/L 6. Time during 14 day continuous glucose monitoring spent below target range <3.9mmol/L (70mg/dl) 7 | — |
Countries
United Kingdom
Contacts
Public ContactKatey Flowers
Outcome results
None listed