Brian Kennon

Lower-limb risk factors for falls in people with diabetes mellitus

Diabet. Med. 27, 162–168 (2010)

Reduced Incidence of Lower-Extremity Amputations in People with Diabetes in Scotland: A nationwide study

OBJECTIVE To establish the incidence of nontraumatic lower-extremity amputation (LEA) in people with diabetes in Scotland. RESEARCH DESIGN AND METHODS This cohort study linked national morbidity records and diabetes datasets to establish the number of people with diabetes who underwent nontraumatic major and minor LEA in Scotland from 2004 to 2008. RESULTS Two thousand three hundred eighty-two individuals with diabetes underwent a nontraumatic LEA between 2004 and 2008; 57.1% (n = 1,359) underwent major LEAs. The incidence of any LEA among persons with diabetes fell over the 5-year study period by 29.8% (3.04 per 1,000 in 2004 to 2.13 per 1,000 in 2008, P < 0.001). Major LEA rates decreased by 40.7% from 1.87 per 1,000 in 2004 to 1.11 per 1,000 in 2008 (P < 0.001). CONCLUSIONS There has been a significant reduction in the incidence of LEA in persons with diabetes in Scotland between 2004 and 2008, principally explained by a reduction in major amputation.

Trends in recorded capillary blood glucose and hypoglycaemia in hospitalised patients with diabetes

AIMS To utilise whole-system analysis of capillary glucose measurement results to examine trends in timing of glucose monitoring, and to investigate whether these timings are appropriate based on observed patterns of hypoglycaemia. METHODS Near-patient capillary blood glucose results from eight acute hospitals collected over 57 months were analysed. Analysis of frequency of measurement, and measurements in the hypoglycaemic (<4mmol/l) and severe hypoglycaemic (<2.5mol/l) range per time of day was made. RESULTS 3345241 capillary glucose measurements were analysed. 1657594 capillary blood glucose values were associated with 106624 admissions in those categorised as having diabetes. Large peaks in frequency of glucose measurements occurred before meals, with the highest frequency of capillary glucose measurement activity being seen pre-breakfast. Overnight, an increase in measurement activity was seen each hour. This pattern was mirrored by frequency of measured hypoglycaemia. 27968 admissions (26.2%) were associated with at least one hypoglycaemic measurement. A greater proportion of measurements were within the hypoglycaemic range overnight with 61.7% of all hypoglycaemia between 2100 and 0900h, with peak risk of measured capillary glucose being hypoglycaemic between 0300 and 0400h. CONCLUSIONS Hypoglycaemic is common with the greatest risk of hypoglycaemia overnight and a peak percentage of all readings taken being in the hypoglycaemic range between 0300 and 0400h. Measurement activity overnight was driven by routine, with patterns of proportion of measurements in the hypoglycaemic range indicating that there may be a significant burden of undiscovered hypoglycaemia in the patients not routinely checked overnight.

Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)

Objective To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. Design Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial). Setting Eight secondary care centres in England and Scotland. Participants Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment (“dose adjustment for normal eating,” DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections. Interventions Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main outcome measures The primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. Results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was −0.85% with pump treatment and −0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was −0.24% (−2.7 mmol/mol) in favour of pump users (95% confidence interval −0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. Conclusions Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants’ level of engagement in intensive self management have been determined. Trial registration Current Controlled Trials ISRCTN61215213.

Beating type 2 diabetes into remission

Recognising and accurately coding reversal of type 2 diabetes is key to improving outcomes and reducing healthcare costs, argue Louise McCombie and colleagues

The impact of gender, level of amputation and diabetes on prosthetic fit rates following major lower extremity amputation

Background: Diabetes mellitus is a leading cause of major lower extremity amputation. Objective: To examine the influence of gender, level of amputation and diabetes mellitus status on being fit with a prosthetic limb following lower extremity amputation for peripheral arterial disease. Study design: Retrospective analysis of the Scottish Physiotherapy Amputee Research Group dataset. Results: Within the cohort with peripheral arterial disease (n = 1735), 64% were men (n = 1112) and 48% (n = 834) had diabetes mellitus. Those with diabetes mellitus were younger than those without: mean 67.5 and 71.1 years, respectively (p < 0.001). Trans-tibial amputation:trans-femoral amputation ratio was 2.33 in those with diabetes mellitus, and 0.93 in those without. A total of 41% of those with diabetes mellitus were successfully fit with a prosthetic limb compared to 38% of those without diabetes mellitus. Male gender positively predicted fitting with a prosthetic limb at both trans-tibial amputation (p = 0.001) and trans-femoral amputation (p = 0.001) levels. Bilateral amputations and increasing age were negative predictors of fitting with a prosthetic limb (p < 0.001). Diabetes mellitus negatively predicted fitting with a prosthetic limb at trans-femoral amputation level (p < 0.001). Mortality was 17% for the cohort, 22% when the amputation was at trans-femoral amputation level. Conclusion: Of those with lower extremity amputation as a result of peripheral arterial disease, those with diabetes mellitus were younger, and more had trans-tibial amputation. Although both age and amputation level are good predictors of fitting with a prosthetic limb, successful limb fit rates were no better than those without diabetes mellitus. Clinical relevance This is of clinical relevance to those who are involved in the decision-making process of prosthetic fitting following major amputation for dysvascular and diabetes aetiologies.

Factors influencing quality of life following lower limb amputation for peripheral arterial occlusive disease: A systematic review of the literature:

Background: The majority of lower limb amputations are undertaken in people with peripheral arterial occlusive disease, and approximately 50% have diabetes. Quality of life is an important outcome in lower limb amputations; little is known about what influences it, and therefore how to improve it. Objectives: The aim of this systematic review was to identify the factors that influence quality of life after lower limb amputation for peripheral arterial occlusive disease. Methods: MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science and Cochrane databases were searched to identify articles that quantitatively measured quality of life in those with a lower limb amputation for peripheral arterial occlusive disease. Articles were quality assessed by two assessors, evidence tables summarised each article and a narrative synthesis was performed. Study design: Systematic review. Results: Twelve articles were included. Study designs and outcome measures used varied. Quality assessment scores ranged from 36% to 92%. The ability to walk successfully with a prosthesis had the greatest positive impact on quality of life. A trans-femoral amputation was negatively associated with quality of life due to increased difficulty in walking with a prosthesis. Other factors such as older age, being male, longer time since amputation, level of social support and presence of diabetes also negatively affected quality of life. Conclusion: Being able to walk with a prosthesis is of primary importance to improve quality of life for people with lower limb amputation due to peripheral arterial occlusive disease. To further understand and improve the quality of life of this population, there is a need for more prospective longitudinal studies, with a standardised outcome measure. Clinical relevance This is of clinical relevance to those who are involved in the rehabilitation of persons with lower limb amputations. Improved quality of life is associated with successful prosthetic use and focus should be directed toward achieving this.

Medical training and the hospital at night: an oxymoron?

Context  Attempts to reduce doctors’ working hours and streamline postgraduate medical training may mean junior doctors’ out‐of‐hours experience is reduced. It is also proposed that, in the UK, compulsory clinical (Foundation Programme) competencies are to be accomplished in 1 year rather than 2 years as they are at present. This observational study was performed to examine the scope of opportunity available to junior doctors to achieve such competencies while working on a ‘Hospital at Night’ (H@N) team.

Multicenter, randomized controlled, observer-blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes-ProNOx1 study: Randomized controlled study of a nitric oxide wound treatment system

The aim of this multicenter, prospective, observer‐blinded, parallel group, randomized controlled trial was to assess the safety and efficacy of EDX110, a nitric oxide generating medical device, in the treatment of diabetic foot ulcers in a patient group reflecting “real world” clinical practice compared against optimal standard care. Participants were recruited from ten hospital sites in multidisciplinary foot ulcer clinics. The ulcers were full thickness, with an area of 25–2,500 mm2 and either a palpable pedal pulse or ankle brachial pressure index > 0.5. Infected ulcers were included. Treatment lasted 12 weeks, or until healed, with a 12‐week follow‐up period. Both arms were given optimal debridement, offloading and antimicrobial treatment, the only difference being the fixed used of EDX110 as the wound dressing in the EDX110 group. 135 participants were recruited with 148 ulcers (EDX110—75; Control—73), 30% of which were clinically infected at baseline. EDX110 achieved its primary endpoint by attaining a median Percentage Area Reduction of 88.6% compared to 46.9% for the control group (p = 0.016) at 12 weeks in the intention‐to‐treat population. There was no significant difference between wound size reduction achieved by EDX110 after 4 weeks and the wound size reduction achieved in the control group after 12 weeks. EDX110 was well tolerated. Thirty serious adverse events were reported (12 in the EDX110 group, of which 4 were related to the ulcer; 18 in the control group, of which 10 were related and 1 possibly related to the ulcer), with significant reduction in serious adverse events related to the ulcer in EDX group. There was no significant difference in adverse events. This study, in a real world clinical foot ulcer population, demonstrates the ability of EDX110 to improve healing, as measured by significantly reducing the ulcer area, compared to current best clinical practice.

Diabetic foot infection: Antibiotic therapy and good practice recommendations

Healthcare events related to diabetic foot disease carry a burden of morbidity, mortality and economic cost. Prompt identification of clinical infection with appropriate tissue sampling limits use of broad spectrum empirical antibiotics and improves antibiotic stewardship. Staphylococcus aureus remains the commonest infecting organism and high‐dose flucloxacillin remains the empirical antibiotic of choice for antibiotic naïve patients. Barriers to microbe‐specific treatment include: adequate tissue sampling, delays in culture results, drug allergies and the emergence of multidrug‐resistant organisms which can complicate the choice of targeted antibiotics. Even appropriate antibiotic treatment carries a risk of adverse events including the selection of resistant organisms.