How and why do patients with Type 1 diabetes sustain their use of flexible intensive insulin therapy? A qualitative longitudinal investigation of patients' self-management practices following attendance at a Dose Adjustment for Normal Eating (DAFNE) course. Explaining engagement in self-monitoring among participants of the DESMOND Self-monitoring Trial: a qualitative interview study. Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study. A nurse‐led interdisciplinary approach to promote self‐management of type 2 diabetes: a process evaluation of post‐intervention experiences Implementation and evaluation of a decision support system for type II diabetes. Training in flexible, intensive insulin management to enable dietary freedom in people with Type 1 diabetes: dose adjustment for normal eating (DAFNE) randomized controlled trial Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial Type 2 diabetes patients educated by other patients perform at least as well as patients trained by professionals. Long-term effects of a structured intensive diabetes education programme (SIDEP) in patients with Type 2 diabetes mellitus--a 4-year follow-up study. Quality of diabetes care, diabetes knowledge and risk of severe hypoglycaemia one and four years after participation in a 5-day structured treatment and teaching programme for intensified insulin therapy. A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial. Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study New Models of Self-Management Education for Minority Ethnic Groups: Pilot Randomized Trial of a Story-Sharing Intervention The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial. Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type 1 diabetes. One-to-one teaching with pictures--flashcard health education for British Asians with diabetes. Multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: the Microalbuminuria Education and Medication Optimisation (MEMO) study. Factors affecting feasibility and acceptability of a practice-based educational intervention to support evidence-based prescribing: a qualitative study. Flexible eating and flexible insulin dosing in patients with diabetes: Results of an intensive self-management course. The impact of a social network based intervention on self-management behaviours among patients with type 2 diabetes living in socioeconomically deprived neighbourhoods: a mixed methods approach A randomized pilot study in Type 1 diabetes complicated by severe hypoglycaemia, comparing rigorous hypoglycaemia avoidance with insulin analogue therapy, CSII or education alone. Effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes: a systematic review
BACKGROUND Conventional insulin therapy requires patients with Type 1 diabetes to adhere to rigid dietary and insulin injection practice s. Recent trends towards flexible intensive insulin therapy enable patients to match insulin to dietary intake and lifestyle ; however , little work has examined patients ' experiences of incorporating these practice s into real-life context s. This qualitative longitudinal study explored patients ' experiences of using flexible intensive insulin therapy to help inform the development of effective long-term support . METHODS Semi-structured interviews were conducted with 30 adult patients with Type 1 diabetes following participation in a structured education programme on using flexible intensive insulin therapy , and 6 and 12 months post-course .  Longitudinal data analysis used an inductive , thematic approach . RESULTS Patients consistently reported feeling committed to and wanting to sustain flexible intensive insulin therapy .  This regimen was seen as a logical and effective method of self-management , as patients experienced improved blood glucose readings and /or reported feeling better . Implementing and sustaining flexible intensive insulin therapy was enhanced when patients had stable routines , with more challenges reported by those working irregular hours and during weekends/holidays . Some patients re-crafted their lives to make this approach work for them ; for instance , by creating dietary routines or adjusting dietary choices . CONCLUSIONS Clinical data have shown that flexible intensive insulin therapy can lead to improvement in glycaemic control . This study , drawing on patients ' perspectives , provides further endorsement for flexible intensive insulin therapy by demonstrating patients ' liking of , and their motivation to sustain , this approach over time . To help patients implement and sustain flexible intensive insulin therapy , follow-up support should encourage them to identify routines to better integrate this regimen into their lives BACKGROUND The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed ( DESMOND ) Self-monitoring Trial reported that people with newly diagnosed type 2 diabetes attending community-based structured education and r and omized to self-monitoring of blood glucose ( SMBG ) or urine monitoring  had comparable improvements in biomedical outcomes , but differences in satisfaction with , and continued use of monitoring method , well-being and perceived threat from diabetes . OBJECTIVES To explore experiences of SMBG and urine monitoring following structured education . We specifically addressed the perceived usefulness of each monitoring method and the associated well-being . METHODS Qualitative semi-structured interviews with 18 adults with newly diagnosed type 2 diabetes participating in the DESMOND Self-monitoring Trial ( SMBG , N=10 ; urine monitoring , N=8)~12 months into the trial . Analysis was informed by the constant comparative approach . RESULTS Interviewees reported SMBG as accurate , convenient and useful . Declining use was explained by having established a pattern of managing blood glucose with less frequent monitoring or lack of feedback or encouragement from health care professionals . Many initially positive views of urine monitoring progressively changed due to perceived inaccuracy , leading some to switch to SMBG . Perceiving diabetes as less serious was attributable to lack of symptoms , treatment with diet alone and -in the urine-monitoring group-consistently negative readings . Urine monitoring also provided less visible evidence of diabetes and of the effect of behaviour on glucose . CONCLUSIONS The findings highlight the importance for professionals of considering patients ' preferences when using self-monitoring technologies , including how these change over time , when supporting the self-care behaviours of people with type 2 diabetes Background The benefit of self-monitoring of blood glucose ( SMBG ) in people with type 2 diabetes on diet or oral agents other than sulphonylureas  remains uncertain . Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results . A recent systematic review concluded that SMBG was not cost-effective . However , what was unclear was whether a cheaper method of self-monitoring ( such as urine glucose monitoring ) could produce comparable benefit and patient acceptability for less cost . Methods / Design The DESMOND SMBG trial is comparing two monitoring strategies ( blood glucose monitoring and urine testing ) over 18 months when incorporated into a comprehensive self-management structured education programme . It is a multi-site cluster r and omised controlled trial , conducted across 8 sites ( 7 primary care trusts ) in Engl and , UK involving individuals with newly diagnosed Type 2 diabetes . The trial has 80 % power to demonstrate equivalence in mean HbA1c ( the primary end-point ) at 18 months of within ± 0.5 % assuming 20 % drop out and 20 % non-consent . Secondary end-points include blood pressure , lipids , body weight and psychosocial measures as well as a qualitative sub- study . Practice s were r and omised to one of two arms : participants attend a  DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose . The programme is delivered by accredited educators who received specific training about equipoise . Biomedical data are collected and psychosocial scales completed at baseline , and 6 , 12 , and 18 months post programme . Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring . Discussion The DESMOND SMBG trial is design ed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes . Strengths include a setting in primary care , a cluster design , a health economic analysis , a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub- study .Trial registration IS RCT N : IS RCT N95696668 BACKGROUND Type 1 diabetes ( T1D ) in children and young people is increasing worldwide with a particular increase in children under the age of 5 years . Fewer than one in six children and young people achieve glycosylated fraction of haemoglobin ( HbA1c ) values in the range identified as providing best future outcomes . There is an urgent need for clinic-based pragmatic , feasible and effective interventions that improve both glycaemic control and quality of life ( QoL ) . The intervention offers both structured education , to ensure young people know what they need to know , and a delivery model design ed to motivate self-management . OBJECTIVE To assess the feasibility of providing a clinic-based structured educational group programme incorporating psychological approaches to improve long-term glycaemic control , QoL and psychosocial functioning in a diverse range of young people . DESIGN The study was a pragmatic , cluster r and omised control trial with integral process and economic evaluation . SETTING Twenty-eight paediatric diabetes services across London , south-east Engl and and the Midl and s. R AND OMISATION Minimised by clinic size , age ( paediatric or adolescent ) and specialisation ( district general hospital clinic or teaching hospital/tertiary clinic ) . ALLOCATION Half of the sites were r and omised to the intervention arm and half to the control arm . Allocation was concealed until after clinics had consented and the first participant was recruited . Where possible , families were blind to allocation until recruitment finished . PARTICIPANTS Forty-three health-care practitioners ( 14 teams ) were trained in the intervention . The study recruited 362 children aged 8 - 16 years , diagnosed with T1D for > 12 months , with a mean 12-month HbA1c level of ≥ 8.5 % . INTERVENTION Two 1-day workshops taught intervention delivery . A detailed manual and re sources were provided . The intervention consists of four group education sessions led by a paediatric diabetes specialist nurse with another team member . OUTCOMES The primary outcome was glycaemic control , assessed at the individual level using venous HbA1c values , measured at baseline , 12 and 24 months . Secondary outcomes were directly and indirectly related to diabetes management , including hypoglycaemic episodes , hospital admissions , diabetes regimen , knowledge , skills and responsibility for diabetes management , intervention compliance , clinic utilisation , emotional and behavioural adjustment , and general and diabetes-specific QoL. PROCESS EVALUATION Question naires , semistructured interviews , informal discussion following observation sessions , fieldwork notes and case note review were used to collect qualitative and quantitative data from key stakeholder groups at specific time points in the trial . STATISTICAL ANALYSES Primary and secondary analyses were intention-to-treat comparisons of outcomes at 12 and 24 months , using analysis of covariance with a r and om effect for clinic . Prespecified subgroup analyses based on age , gender , initial HbA1c value and socioeconomic status were estimated from models that included an interaction term . The economic analysis compared long-term costs and predicted quality -adjusted life-years ( QALYs ) . RESULTS The intervention did not improve HbA1c at 12 months [ intervention effect 0.11 ; 95 % confidence interval ( CI ) -0.28 to 0.50 ; p = 0.584 ] or 24 months ( intervention effect 0.03 ; 95 % CI -0.36 to 0.41 ; p = 0.891 ) . A total of 298/362 patients ( 82.3 % ) provided blood sample s at 12-month follow-up , and 284/362 ( 78.5 % ) provided blood sample s at 24-month follow-up . Follow-up question naires were completed by 307 patients ( 85.3 % ) at 12 months and by 295 patients ( 81.5 % ) at 24 months . Intervention group parents at 12 months ( 95 % CI 0.74 ; 0.03 to 1.52 ) and young people at 24 months ( 0.85 ; 95 % CI 0.03 to 1.61 ) had higher scores on the diabetes family responsibility question naire . Young people reported reduced happiness with body weight at 12 months ( -0.56 ; 95 % CI -1.03 to -0.06 ) . Only 68 % of groups were run . Of the 180 families recruited , 96 ( 53 % ) attended at least one module . Reasons for low uptake included difficulties organising groups , and work and school commitments . Young people with higher HbA1c levels were less likely to attend . Parents and young people who attended groups described improved family relationships , improved knowledge and underst and ing , greater confidence and increased motivation to manage diabetes . Twenty-four months after the intervention , nearly half of the young people reported that the groups had made them want to try harder and that they had carried on trying . A high- quality , complex , pragmatic trial of structured education can be delivered alongside st and ard care in NHS diabetes clinics . Health-care providers benefited from behaviour change skill training and can deliver pragmatic aspects of a National Institute for Health and Care Excellence (NICE)-compliant structured education programme after relatively brief training . The process evaluation provides insight into aspects of the model , and highlights strengths and aspects that may have contributed to the failure to influence primary and secondary outcomes . Current NHS practice dominates CASCADE ( Child and Adolescent Structured Competencies Approach to Diabetes Education ) in that it achieves the same number of QALYs at a lower cost . The mean cost of providing the intervention was £ 5098 per site or £ 683 per child . Members of paediatric diabetes services trained to deliver the CASCADE structured education package using behaviour change techniques did not improve glycaemic control in patients compared with control subjects 1 and 2 years after the intervention . The training workshops for practitioners were well evaluated ; however , more intensive training was needed . The intervention cost £ 683 per patient but was not cost-effective because it did not improve metabolic control . CONCLUSIONS A high- quality , complex , pragmatic trial of structured education can be successfully conducted alongside st and ard care in NHS diabetes clinics . Pragmatic components of a NICE-compliant structured education programme can be successfully delivered following a relatively brief 2-day training while paediatric health-care professionals benefit from training in behaviour change skills . The study provides invaluable information on barriers and opportunities regarding future , similar interventions . A low dropout rate and good attendance for the subgroup that attended the intervention suggests there might be improved uptake if offered to young people with lower HbA1c . Testing whether this approach can be more successful with a robust ongoing supervisory element should be a target of further research . TRIAL REGISTRATION Current Controlled Trials IS RCT N52537669 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 18 , No. 20 . See the NIHR Journals Library website for further project information RATIONALE , AIMS AND OBJECTIVES Self-management of type 2 diabetes through diet , exercise and for many medications , are vital in achieving and maintaining glycaemic control in type 2 diabetes . A number of interventions have been design ed to improve self-management , but the outcomes of these are rarely explored from a qualitative angle and even fewer through a process evaluation . METHOD A process evaluation was conducted using a qualitative design with participants r and omized to an intervention . Seventy-three people living with type 2 diabetes and hyperglycaemia for a minimum of 1 year , r and omized to one of two interventions ( n = 34 to an education intervention and n = 39 to an education and acceptance and commitment therapy intervention )  completed stage one of the process evaluation , immediately following the intervention through written feedback guided by open-ended questions . A purposive sample of 27 participants completed semi-structured interviews at 3 and 6 months post intervention . Interview data were transcribed and data analysed using a thematic analysis . RESULTS The majority of participants described an increase in knowledge around diabetes self-management and an increased sense of personal responsibility . Participants also described changes in self-management activities and reflected on the challenges in instigating and maintaining change to improve diabetes management . CONCLUSION The complexities of implementing change in daily life to improve glycaemic control indicate the need for ongoing support post intervention , which may increase and maintain the effectiveness of the intervention A decision support system for the management of  oral hypoglycaemic therapy  in type II diabetes was evaluated . The ruleset contained therein forms the basis of a prototype computer programme , but in order to assess the robustness of the individual rules , it was decided it was necessary to use a paper-based form of the ruleset . A nurse with no previous experience of managing type II diabetes was trained to use the system and then undertook the exclusive management of half of all new type II diabetics , from a district population of 300,000 , over a 16-month period . General practice s within this area were divided into two groups , study and control , matching for size , geographical area and st and ards of existing diabetes care . Patients ( n = 102 ) from the study group practice s were then assigned to her care . Those patients ( n = 116 ) in the control group of practice s were treated according to their normal procedures . The decision support system for oral hypoglycaemic therapy was based on the following criteria : the current type of treatment ( six levels ) ; current glycaemic control ( HbA1 and FBS)-whether improving , steady or worsening ; and weight-%IBW , whether rising , steady or falling . Each of these parameters was carefully defined on the basis of established practice and clinical experience . Patients after initial education were seen at their usual clinic by the nurse only , on a monthly basis , until satisfactory glycaemic control was established and thereafter review ed 3 monthly . She was also responsible for ensuring the organisation of Diabetes Annual Review procedures . The medical records of the control group patients were examined at the end of the study and data on glycaemic control and Annual Review s extracted . In the study group 98 % patients achieved HbA1 levels within the normal range and all patients had full annual review s performed . The control practice s achieved much poorer degrees of metabolic control ( P < 0.01 ) and completed fewer annual review s. The study group did not demonstrate a significantly increased frequency of clinical hypoglycaemia consequent upon better blood sugar control . No exceptions to the ruleset , as initially defined , were detected . In conclusion , this decision support system was successful at achieving st and ards of diabetes control and care equal to or better than conventional structures of diabetes care . Implementation of such a system , on a simple computer platform , could greatly assist and possibly improve diabetes management in general practice Objectives To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes . Design R and omised design with participants either attending training immediately ( immediate DAFNE ) or acting as waiting list controls and attending “ delayed DAFNE ” training 6 months later . Setting Secondary care diabetes clinics in three English health districts . Participants 169 adults with type 1 diabetes and moderate or poor glycaemic control . Main outcome measures Glycated haemoglobin ( HbA1c ) , severe hypoglycaemia , impact of diabetes on quality of life ( ADDQoL ) . Results At 6 months , HbA1c was significantly better in immediate DAFNE patients ( mean 8.4 % ) than in delayed DAFNE patients ( 9.4 % ) ( t=6.1 , P < 0.0001 ) . The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients ( t= − 5.4 , P < 0.0001 ) , as was the impact of diabetes on overall quality of life ( t=2.9 , P < 0.01 ) . General wellbeing and treatment satisfaction were also significantly improved , but severe hypoglycaemia , weight , and lipids remained unchanged . Improvements in “ present quality of life ” did not reach significance at 6 months but were significant by 1 year . Conclusion Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk . This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation Abstract Objectives : To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes . Design : R and omised design with participants either attending training immediately ( immediate DAFNE ) or acting as waiting list controls and attending “ delayed DAFNE ” training 6 months later . Setting : Secondary care diabetes clinics in three English health districts . Participants : 169 adults with type 1 diabetes and moderate or poor glycaemic control . Main outcome measures : Glycated haemoglobin ( HbA1c ) , severe hypoglycaemia , impact of diabetes on quality of life ( ADDQoL ) . Results : At 6 months , HbA1c was significantly better in immediate DAFNE patients ( mean 8.4 % ) than in delayed DAFNE patients ( 9.4 % ) ( t=6.1 , P<0.0001 ) . The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients ( t=−5.4 , P<0.0001 ) , as was the impact of diabetes on overall quality of life ( t=2.9 , P<0.01 ) . General wellbeing and treatment satisfaction were also significantly improved , but severe hypoglycaemia , weight , and lipids remained unchanged . Improvements in “ present quality of life ” did not reach significance at 6 months but were significant by 1 year . Conclusion : Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk . This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation BACKGROUND Diabetes education can improve the quality of care of people with diabetes , but many organizations are not equipped to manage its implementation . Involving people with diabetes in the education process can overcome the problem . Thus , we compared clinical , metabolic and psychological outcomes in people with type 2 diabetes 1 year after attending a structured diabetes education programme implemented by professional educators versus the same programme implemented by trained peers with diabetes  that also provided ongoing peer support . METHODS People with type 2 diabetes ( 25 - 75 years ) were r and omly assigned to attend a 4-week structured diabetes education course delivered by professional educators ( control ) or previously trained peers ( peer ) . Peers also received continuing psychological support , including examples on how to apply diabetes knowledge in daily life via weekly peer cellular phone calls and bimonthly face-to-face interviews in small groups ( ten patients ) , using a structured question naire related to the patient 's clinical , metabolic and psychological progress . Identical outcome data from both groups were used for follow-up . RESULTS Both groups had a comparable positive effect on clinical , metabolic and psychological indicators immediately following the programme . Over the following year , peer-educated subjects had lower A(1C ) and systolic blood pressure and showed higher adherence to physical activity and better control of hypoglycaemic episodes . CONCLUSION The non-inferiority of the peer outcomes and the mentioned improvements in this group suggest that volunteer trained peer educators and ongoing support can be successful . This approach provides an effective alternative method of education , especially in areas with limited availability of professionals and economic re sources AIMS Patient education is a very important part of diabetes care . However , until now , little data has been presented about the long-term effectiveness of structured intensive diabetes education programmes ( SIDEP ) for people with Type 2 diabetes mellitus . METHODS People with Type 2 diabetes ( n = 547 ) hospitalized from December 1999 to December 2000 were r and omly assigned to two groups . Two hundred and nineteen patients undertook an inpatient SIDEP and the remaining patients received conventional glycaemic control without intensive education . After discharge , all patients were monitored regularly . Laboratory data were obtained , and adherence to self-care behaviour was determined on a five-point scale by question naires completed annually . RESULTS Of the patients who completed the SIDEP , 160 ( 73.1 % ) were followed up for more than 4 years . The mean HbA(1c ) ( 7.9 + /- 1.2 vs. 8.7 + /- 1.6 % ; P < 0.05 ) and the frequency of hospitalization related to diabetes per patient per year ( 0.3 + /- 0.6 vs. 0.8 + /- 0.9 ; P < 0.05 ) was significantly lower in the SIDEP group than in the control group . The SIDEP group adhered more closely to self-care behaviour than the control group over 4 years ( P < 0.05 ) . People with Type 2 diabetes mellitus of longer duration and those treated with insulin had poorer HbA(1c ) at follow-up . CONCLUSIONS A well- design ed , intensive patient education programme is necessary for people with diabetes . However , regular and sustained reinforcement with encouragement is also required to maintain optimal glycaemic control , especially in insulin-treated patients Intensification of insulin therapy in the Diabetes Control and Complications Trial led to an improvement in the quality of diabetes care , which was accompanied , however , by a threefold increase in the risk of severe hypoglycaemia . The present trial , a long-term evaluation of a structured 5-day treatment and teaching programme ( DTTP ) for intensified insulin therapy , was performed to clarify factors determining HbA1c , the incidence of severe hypoglycaemia , diabetes knowledge and quality of life .  Ninety-four Type 1 diabetic patients were examined at baseline and 4 years after participation in a DTTP .  Comparison of baseline data with measurements at the 4-year follow-up examination showed that relative HbA1c (= HbA1c/mean normal ) improved ( 1.9 + /- 0.51 vs 1.55 + /- 0.3 * , p < 0.001 , * excluding 4 patients with diabetes manifestation at baseline ) and that frequencies of daily insulin injections ( 3.73 + /- 1.23 vs 4.9 + /- 0.69 * , p < 0.001 ) and weekly blood glucose self-tests ( 6.6 + /- 10.1 vs 25.5 + /- 8.7 * , p < 0.001 ) increased , whereas the incidence of severe hypoglycaemia ( intravenous glucose , glucagon injection ) remained stable ( 0.19 vs 0.24 , p = 0.48 ) . Patients with less diabetes knowledge  had higher HbA1c levels and a higher incidence of severe hypoglycaemia . In the group of patients with severe hypoglycaemia , certain crucial gaps in diabetes knowledge were identified concerning the effects of physical activity , nutrition and long-term complications of diabetes . In multivariate analysis . The most important factor associated with HbA1c was diabetes knowledge which , however , was not influenced by educational level or other factors . Interventions , such as the identification of psychosocial factors which may interact with diabetes knowledge , quality of life and successful self-management of diabetes by patients , are needed to improve the efficacy of DTTPs and to prevent severe side effects such as hypoglycaemia BACKGROUND Insulin is generally administered to people with type 1 diabetes mellitus ( T1DM ) using multiple daily injections ( MDIs ) , but can also be delivered using infusion pumps . In the UK , pumps are recommended for patients with the greatest need and adult use is less than in comparable countries . Previous trials have been small , of short duration and have failed to control for training in insulin adjustment . OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM , with both groups receiving equivalent structured training in flexible insulin therapy . DESIGN Pragmatic , multicentre , open-label , parallel-group cluster r and omised controlled trial , including economic and psychosocial evaluations . After participants were assigned a group training course , courses were r and omly allocated in pairs to either pump or MDI . SETTING Eight secondary care diabetes centres in the UK . PARTICIPANTS Adults with T1DM for > 12 months , willing to undertake intensive insulin therapy , with no preference for pump or MDI , or a clinical indication for pumps . INTERVENTIONS Pump or MDI structured training in flexible insulin therapy , followed up for 2 years . MDI participants used insulin analogues . Pump participants used a Medtronic Paradigm ® VeoTM ( Medtronic , Watford , UK ) with insulin aspart ( NovoRapid , Novo Nordisk , Gatwick , UK ) . MAIN OUTCOME MEASURES Primary outcome - change in glycated haemoglobin ( HbA1c ) at 2 years in participants whose baseline HbA1c was ≥ 7.5 % ( 58 mmol/mol ) . Key secondary outcome - proportion of participants with HbA1c ≤ 7.5 % at 2 years . Other outcomes at 6 , 12 and 24 months - moderate and severe hypoglycaemia ; insulin dose ; body weight ; proteinuria ; diabetic ketoacidosis ; quality of life ( QoL ) ; fear of hypoglycaemia ; treatment satisfaction ; emotional well-being ; qualitative interviews with participants and staff ( 2 weeks ) , and participants ( 6 months ) ; and ICERs in trial and modelled estimates of cost-effectiveness . RESULTS We r and omised 46 courses comprising 317 participants : 267 attended a Dose Adjustment For Normal Eating course ( 132 pump ; 135 MDI ) ; 260 were included in the intention-to-treat analysis , of which 235 ( 119 pump ; 116 MDI ) had baseline HbA1c of ≥ 7.5 % . HbA1c and severe hypoglycaemia improved in both groups . The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI . The mean difference ( MD ) in HbA1c change at 2 years , at which the baseline HbA1c was ≥ 7.5 % , was -0.24 % [ 95 % confidence interval ( CI ) -0.53 % to 0.05 % ] in favour of the pump ( p = 0.098 ) . The per- protocol analysis showed a MD in change of -0.36 % ( 95 % CI -0.64 % to -0.07 % ) favouring pumps ( p = 0.015 ) . Pumps were not cost-effective in the base case and all of the sensitivity analyses . The pump group had greater improvement in diabetes-specific QoL diet restrictions , daily hassle plus treatment satisfaction , statistically significant at 12 and 24 months and supported by qualitative interviews . LIMITATION Blinding of pump therapy was not possible , although an objective primary outcome was used . CONCLUSION Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM . RESEARCH PRIORITY To underst and why few patients achieve a HbA1c of < 7.5 % , particularly as glycaemic control is worse in the UK than in other European countries . TRIAL REGISTRATION Current Controlled Trials IS RCT N61215213 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 21 , No. 20 . See the NIHR Journals Library website for further project information Aims /hypothesisThe aim of this study was to evaluate the implementation of a course teaching flexible , intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care . Methods This is a continuous quality -assurance project involving hospital diabetes centres . Every third year each centre re-examines 50 consecutive patients ( evaluation sample ) 1 year after participation in the course . Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes ( 190 evaluation sample s ) were re-examined between 1992 and 2004 . The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment . The main outcome measures were HbA1c and severe hypoglycaemia . Results Mean baseline HbA1c was 8.1 % , and had decreased to 7.3 % at follow-up ; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention . In mixed-effects models adjusted for effects of centres , age and diabetes duration , the mean difference was −0.7 % ( 95 % CI −0.9 to −0.6 % , p<0.0001 ) for HbA1c and −0.21 events per patient per year ( 95 % CI −0.32 to −0.11 , p=0.0001 ) for severe hypoglycaemia , with similar results for evaluation sample s , with a maximum of 10 % of patients lost to follow-up . Before intervention , the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA1c , whereas the risk was comparable across the range of HbA1c values after intervention . Conclusions /interpretationImplemented as part of a continuous quality -assurance programme the self-management programme is effective and safe in routine care . Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia Objective No model of self-management education or peer support has yet achieved widespread reach and acceptability with minority ethnic groups . We sought to refine and test a new complex intervention in diabetes education : informal story-sharing groups facilitated by bilingual health advocates . Methods Pilot r and omized trial with in-depth process evaluation in a socioeconomically deprived area . 157 people referred for diabetes education were r and omized by concealed allocation to an intervention ( storysharing group in their own language ) or control ( ‘ usual care ’ self-management education , through an interpreter if necessary ) arm . Story-sharing groups were held in five ethnic language s and English ( for African Caribbeans ) , and ran fortnightly for six months . Primary outcome was UKPDS ( UK Prospect i ve Diabetes Study ) risk score . Secondary outcomes included attendance , HbA1c , well-being and enablement . Process measures included ethnographic observation , and qualitative interviews with staff and patients . Results Some follow-up data were obtained on 87 % of participants . There was no significant difference between intervention and control arms in biomedical outcomes . Attendance was 79 % in the story-sharing arm and 35 % in the control arm ( p < 0.0001 ) , and patient enablement scores were significantly higher ( 8.3 compared to 5.9 , p < 0.005 ) . The model was very popular with clinicians , managers and patients , which helped overcome numerous challenges to its successful embedding in a busy public sector diabetes service . Conclusion People from minority ethnic groups in a socioeconomically deprived area were keen to attend informal story-sharing groups and felt empowered by them , but clinical outcomes were no better than with conventional education . Further research is needed to maximize the potential and evaluate the place of this appealing service model before it is introduced as a part of mainstream diabetes services BACKGROUND Although maintaining nearly normal glycemia delays onset and slows progression of diabetes complications , many patients with diabetes and their physicians struggle to achieve glycemic targets . The best methods to support patients as they follow diabetes prescriptions and recommendations are unclear . METHODS To test the efficacy of a behavioral diabetes intervention in improving glycemia in long- duration , poorly controlled diabetes , we r and omized 222 adults with diabetes ( 49 % type 1 ) ( mean [ SD ] age , 53 [ 12 ] years ; mean [ SD ] disease duration 18 [ 12 ] years ; mean [ SD ] hemoglobin A(1c ) [ HbA(1c ) ] concentration , 9.0 % [ 1.1 % ] ) to attend ( 1 ) a 5-session manual-based , educator-led structured group intervention with cognitive behavioral strategies ( structured behavioral arm ) ; ( 2 ) an educator-led attention control group education program ( group attention control ) ; or ( 3 ) unlimited individual nurse and dietitian education sessions for 6 months ( individual control ) . Outcomes were baseline and 3- , 6- , and 12-month postintervention HbA(1c ) levels ( primary ) and frequency of diabetes self-care , 3-day pedometer readings , 24-hour diet recalls , average number of glucose checks , physical fitness , depression , coping style , self-efficacy , and quality of life ( secondary ) . RESULTS Linear mixed modeling found that all groups showed improved HbA(1c ) levels ( P < .001 ) . However , the structured behavioral arm showed greater improvements than the group and individual control arms ( 3-month HbA(1c ) concentration changes : -0.8 % vs -0.4 % and -0.4 % , respectively ( P = .04 for group × time interaction ) . Furthermore , participants with type 2 disease showed greater improvement than those with type 1 ( P = .04 for type of diabetes × time interaction ) . Quality of life , glucose monitoring , and frequency of diabetes self-care did not differ by intervention over time . CONCLUSIONS A structured , cognitive behavioral program is more effective than 2 control interventions in improving glycemia in adults with long- duration diabetes . Educators can successfully use modified psychological and behavioral strategies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT000142922 AIMS To evaluate the effectiveness of a family-centred group education programme , in adolescents with Type 1 diabetes . METHODS Three hundred and five adolescents with Type 1 diabetes ; age 13.1 ± 1.9 years , diabetes duration 5.6 ± 3.3 years , BMI 20.9 ± 3.7 kg/m(2 ) , HbA(1c ) 78 ± 6 mmol/mol ( 9.3 ± 1.9 % ) were r and omly allocated to the Families and Adolescents Communication and Teamwork Study ( FACTS ) diabetes education programme ; ( six 90-min monthly sessions attended by parents and adolescents incorporating skills training and family teamwork ) or conventional clinical care . Primary outcome was HbA(1c ) at 18 months ( 12 months post-intervention ) . Secondary outcomes were HbA(1c ) at 9 months , psychosocial outcomes , adolescent quality of life , well-being , family responsibility and insulin dose adjustment behaviours at 12 months ( 6 months post-intervention ) and episodes of severe hypoglycaemia and diabetic ketoacidois during the 12 months post-intervention . All analyses are intention to treat . RESULTS Session attendance was poor with 48/158 families ( 30.4 % ) not attending any sessions and only 75/158 ( 47.5 % ) families attending ≥ 4 group education sessions . All biomedical and psychosocial outcomes were comparable between groups . At 18 months there was no significant difference in HbA(1c ) in either group and no between-group differences over time : intervention group 75 mmol/mol ( 9.0 % ) to 78 mmol/mol ( 9.3 % ) , control group 77 mmol/mol ( 9.2 % ) to 80 mmol/mol ( 9.5 % ) . Adolescents perceived no changes in parental input at 12 months . CONCLUSION Poor attendance of group education sessions delivered in routine clinics was a major challenge . More personalized educational approaches may be required to support and motivate families who are struggling to integrate the dem and s of intensive insulin regimens into their daily lives BACKGROUND Type 2 diabetes is up to four times more common in British Asians , but they know little about its management and complications . AIM To design and evaluate a structured pictorial teaching programme for Pakistani Moslem patients in Manchester with type 2 diabetes . METHOD A r and omized controlled trial of pictorial flashcard one-to-one education in 201 patients attending a hospital outpatient clinic or diabetic clinics in ten general practice s in Manchester . Patients ' knowledge , self-caring skills and attitudes to diabetes were measured on four topics before the structured teaching , and compared with results six months later . RESULTS All parameters of knowledge were increased in the study group ; for example , percentage scores for correctly identifying different food values increased from 57 % to 71 % ( Analysis of Variance ( ANOVA ) adjusted difference + 11.8 % ) and knowledge of one diabetic complication from 18 % to 78 % . Self-caring behaviour improved , with 92 % of patients doing regular glucose tests at six months compared with 63 % at the start . Attitudinal views were more resistant to change , with patients still finding it hard to choose suitable foods at social occasions . Haemoglobin A1c control improved by 0.34 % over six months ( ANOVA adjusted difference , 95 % CI -0.8 % to + 0.1 % ) . CONCLUSION It is concluded that this health education programme can empower Asian diabetics to take control of their diets , learn to monitor and interpret glucose results , and underst and the implication s of poor glycaemic control for diabetic complications AIMS To determine whether tighter cardiovascular risk factor control with structured education in individuals with type 2 diabetes ( T2DM ) and microalbuminuria benefits cardiovascular risk factors . METHODS Participants from a multiethnic population , recruited from primary care and specialist clinics were r and omised to intensive intervention with structured patient ( DESMOND model ) education ( n=94 ) or usual care by own health professional ( n=95 ) . PRIMARY OUTCOME change in HbA1c at 18months . SECONDARY OUTCOMES changes in blood pressure ( BP ) , cholesterol , albuminuria , proportion reaching risk factor targets , modelled cardiovascular risk scores . RESULTS Mean ( SD ) age and diabetes duration of participants were 61.5 ( 10.5 ) and 11.5 ( 9.3 ) years , respectively . At 18months , intensive intervention showed significant improvements in HbA1c ( 7.1(1.0 ) vs. 7.8(1.4)% , p<0.0001 ) , systolic BP ( 129(16 ) vs. 139(17 ) mmHg , p<0.0001 ) , diastolic BP ( 70(11 ) vs. 76(12 ) mmHg , p<0.001 ) , total cholesterol ( 3.7(0.8 ) vs. 4.1(0.9 ) mmol/l , p=0.001 ) . Moderate and severe hypoglycaemia was 11.2 vs. 29.0 % ; p=0.001 and 0 vs. 6.3 % ; p=0.07 , respectively . More intensive participants achieved ≥3 risk factor targets with greater reductions in cardiovascular risk scores . CONCLUSIONS Intensive intervention showed greater improvements in metabolic control and cardiovascular risk profile with lower rates of moderate and severe hypoglycaemia . Intensive glycaemic interventions should be underpinned by structured education promoting self-management in T2DM BACKGROUND Inappropriate and costly GP prescribing is a major problem facing Primary Care Trusts .  Educational outreach into practice s , alongside other measures , such as audit and feedback , have the potential to enable GP prescribing to become more evidence based . High GP prescribing costs are associated with GPs who see drug company representatives ; tend to end consultations with prescriptions ; and ' try out ' new drugs on an ' ad hoc basis ' and use this as evidence of the drug 's effect . An educational intervention called ' reflective practice ' was developed to meet these and other educational needs . The design of the intervention was informed by studies that have identified the pre-requisites of successful behaviour change in general practice . OBJECTIVES The study investigated the following : ( i ) Is it feasible for GPs to attend the sessions included in the educational intervention ? ( ii ) Is the intervention acceptable to the participants and the session facilitators ? ( iii ) What are the barriers to the group educational processes , and how can these be overcome ? METHODS Four practice s were recruited in South West Engl and , all of them experiencing problems with prescribing appropriateness and cost .  Reflective practice sessions ( including a video-taped scenario ) were run in each of these practice s and qualitative methods were used to explore the complex attitudes and behaviour of the participants . A research er observed and audio-taped sessions in each practice . At the end of the programme , a sample of doctors and all the facilitators were interviewed about their experiences . The recorded data were transcribed and analysed using st and ard qualitative methods . RESULTS The doctors in the largest partnerships were those who had the greatest difficulty in attending the sessions . Elsewhere , doctors were also reluctant to become involved because of previous experience of top-down managerial initiatives about prescribing quality . Facilitators came from a broad range of professional background s. While knowledge of prescribed drug management issues was important , the professional background of the facilitator was less important than group facilitation skills in creating a group process which participating GPs found satisfactory . The video-taped scenario was found to be useful to set the scene for the discussion . Preserving the anonymity of responses of the GPs in the initial stages of the sessions was important in ensuring honesty in the discussion . Reaching a consensus on management of common conditions was sometimes difficult , partly because the use of the term ' best buy ' implies economic pressures , rather than benefits to patients , and partly because of the value with which GPs regard the concept of clinical autonomy . ' Reflective Practice ' appeared to have the potential to make GPs aware of the link to be made between their clinical management decisions and the evidence provided by the British National Formulary and Clinical Evidence . CONCLUSION The study indicates the importance of preparing the practice adequately , including providing protected time for all GPs to attend the educational intervention . Scenarios and the structure of the sessions need to make more explicit the links between everyday practice and published evidence of effectiveness . Emphasis on cost-effectiveness may be counterproductive and wider benefits need to be emphasized . We have also identified the skill profile of the facilitator role . Our study indicates a need for a clearer underst and ing of GPs ' perception of clinical autonomy and how this conflicts with the goal of agreement on practice guidelines for treatment . The intervention is now ripe for further development , perhaps by integrating it with other interventions to change professional behaviour . The improved intervention should then be evaluated in a r and omized controlled trial AIMS To evaluate the outcomes of an established programme to teach patients to match their insulin dose to their carbohydrate intake . RESEARCH DESIGN AND METHODS A prospect i ve observational study in Australia ( Newcastle , NSW ) of 137 consecutive patients with type 1 ( n=82 ) or type 2 diabetes ( n=55 ) over two successive years . Four educational principles were used to teach intensive insulin management and diabetes self-care skills including : carbohydrate counting and insulin dose adjustment , exercise , appropriate treatment of hypoglycaemia and hyperglycaemia , managing sickness , problem solving , communication with health professionals , goal setting , and the importance of support . Outcomes included changes at 4 and 12 months in HbA1c , self-efficacy measured by a diabetes empowerment scale ( DES ) , diabetes specific quality of life ( ADDQoL ) , and problem solving . Both intention to treat and efficacy analyses were performed . RESULTS Diabetes-related quality of life and diabetes problem solving skills improved significantly . Excluding 16 people who failed to adopt intensive insulin management and 24 who started with an HbA1c less than 7 % , intention to treat analysis showed the average HbA1c fell from 8.7 % initially to 8.1 % at 12 months and the number of people with an HbA1c of less than 8 % rose from 67 ( 48.9 % ) before the program to 86 ( 62.8 % ) afterwards . CONCLUSIONS An intensive diabetes self-management program led to improvements in HbA1c , empowerment , and quality of life that were largely sustained at 1 year . This is all the more remarkable given that the intervention was once only , entailed no long-term follow-up , and took place in normal clinical operations Aims : This paper aims to explore the effect of the social network based intervention Powerful Together with Diabetes on diabetes self-management among socioeconomically deprived patients . This 10-month group intervention targeting patients and significant others aim ed to improve self-management by stimulating social support and diminishing social influences that hinder self-management . Methods : This intervention was evaluated in a quasi-experimental study using a mixed methods approach . Of 131 socioeconomically deprived patients with suboptimal glycaemic control , 69 were assigned to the  intervention  group and 62 to the  control group ( st and ard diabetes education ) . 27 qualitative in-depth interviews with the participants and 24 with their group leaders were held to study the subjective impact of the intervention . Further , self-management behaviours ( medication adherence , diet and physical activity ) were assessed at baseline , 10 and 16 months . Data were analysed using framework analyses and a linear mixture model . Results : Qualitative data showed that the intervention group had a better underst and ing of the way self-management influences diabetes . The intervention group showed more complex self-management behaviours , such as planning ahead , seeking adequate food and physical activity alternatives , and consistently taking their diabetes into consideration when making choices . In participants with complete follow-up data , we found a significant increase in physical activity in the intervention group ( 3.78 vs. 4.83 days ) and no changes in medication adherence and diet . Conclusions : This study indicates that an intensive support group and simultaneously involving significant others might improve diabetes self-management behaviours among socioeconomically deprived patients . More studies are needed to justify further implementation of the intervention . This study is registered in the Dutch Trial Register NTR1886 . http://www.trialregister.nl/trialreg/admin/ rct AIM To determine potential for amelioration of recurrent severe hypoglycaemia without worsening in overall control in individuals with long-st and ing Type 1 diabetes ( T1DM ) . METHODS Twenty-one people with T1DM characterized by altered hypoglycaemia awareness and debilitating severe hypoglycaemia were r and omized in a pilot 24-week prospect i ve study to optimized analogue therapy ( ANALOGUE ; lispro/glargine ) ; continuous subcutaneous insulin infusion therapy ( CSII ; lispro ) ; or re-education with relaxation of blood glucose targets on existing conventional insulin regimen ( EDUCATION ) .  Glycaemic profiles and duration of biochemical hypoglycaemia were measured by continuous subcutaneous glucose monitoring and self-monitored blood glucose . RESULTS Further severe hypoglycaemia was prevented in five participants ( 71 % ) in each group ( P = 0.06 ) . Incidence of severe hypoglycaemia was : 0.6 ( ANALOGUE ) , 0.9 ( CSII ) , and 3.7 ( EDUCATION ) episodes per patient year . Restoration of hypoglycaemia awareness was confirmed by vali date d question naire in three ( 43 % ) ANALOGUE , four ( 57 % ) CSII and five ( 71 % ) EDUCATION patients . Glycated haemoglobin ( HbA1c ) was significantly improved in the ANALOGUE group between weeks 0 and 24 ( 8.6 + /- 1.1 vs. 7.6 + /- 0.8 % ; P = 0.04 for change ) . Non-significant improvement was seen in the CSII group ( 8.5 + /- 1.9 vs. 7.4 + /- 1.0 % ; P = 0.06 ) . No change in HbA1c was seen in the EDUCATION group ( 8.5 + /- 1.1 vs. 8.3 + /- 1.0 % ; P = 0.54 ) . There were no episodes of diabetic ketoacidosis or any other adverse events in any group . CONCLUSIONS In this pilot r and omized trial comparing optimized ANALOGUE , CSII or EDUCATION alone in unselected individuals with recurrent severe hypoglycaemia , we show potential for restoring hypoglycaemia awareness and preventing further severe hypoglycaemia with concomitant improvement in glycaemic control in ANALOGUE and CSII groups Executive summary Background As a chronic condition , the prevalence of Type 2 diabetes is increasing worldwide and adherence to oral medications , an essential component of self‐management , has been shown to improve glycaemic control . However compliance with oral medication adherence remains poor . Educating people with Type 2 diabetes is an important strategy to enhance self‐management ability , including medication‐taking behaviour . Objectives The overall objective of the review was to determine the effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes . Inclusion criteria Types of participants Studies involving adults over 18 years old with Type 2 diabetes , with or without co‐morbidities , currently taking oral hypoglycaemic medication without insulin treatment , and with aglycated haemoglobin ( HbA1c ) > 7.0 % prior to the intervention were considered . Aglycated haemoglobin ( HbA1c ) concentration of less than 7.0 % , is important in order to delay or prevent diabetes‐related complications . Participants could be from the primary , tertiary or acute care setting . Types of intervention The review focused on various forms of educational interventions delivered by healthcare professionals aim ed at improving participants ’ knowledge . Types of outcomes The review evaluated outcomes measuring oral hypoglycaemic adherence including HbA1c , fasting blood glucose levels and other relevant indicators . Types of studies Studies that were r and omized controlled trials ( RCTs ) or case‐control studies were considered . Search strategy A three‐stage search strategy was employed . Papers in English and between the years 1990‐2009 were search ed in the following data bases : CINAHL , Medline , Mosby 's Nursing Consult , PsycINFO , PubMed , ScienceDirect , Scopus , TRIP and Web of Science . Full text was retrieved when the titles and abstract s of studies fulfilled the inclusion criteria . Method ological quality Full papers were assessed for method ological quality independently by two review ers using critical appraisal checklists from the Joanna Briggs Institute ( JBI ) . A third review er was consulted whenever there were disagreements between the two review ers . Data collection / extraction Details of each study included in the review were extracted using st and ardized data extraction forms developed by JBI . Extraction was conducted independently by two review ers . Data synthesis Meta‐ analysis was not possible due to method ological and statistical heterogeneity of the included studies . Hence study findings are presented in narrative form . Results Seven studies included in the final review consisted of seven RCTs . Five studies concluded that the educational intervention was effective in promoting oral hypoglycaemic adherence compared to usual care . These included pharmacist‐led interventions , individual diabetes education provided by nurses and diabetes group education based on a self‐management approach . Similarities among these interventions were provision of information on oral hypoglycaemic medication and the need for regular education sessions . However , small sample s in some studies limited generalization of results . Conclusions Implication s for practice Increased knowledge of oral hypoglycaemic issues and reinforcement of the importance of medication adherence were useful in promoting adherence . Regular education sessions allow individuals to reinforce information and educators to identify barriers to medication adherence . Educational interventions focusing on self‐management strategies appear more likely to achieve positive outcomes . Implication s for research Further trials involving larger sample s and population s with poor glycaemic control are needed . The effects of educational interventions , influence of additional take‐home written material , the optimal interval length of follow‐up and duration of education sessions , and specific processes of individual or group education which have been identified as effective need further exploration
This model outlines the challenges participants encounter in maintaining diabetes self-management practice s after attending structured education , and describes how participants try to address these barriers by adapting , simplifying or personalising the self-management approaches they have learned .
Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour .
Background People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia .
However , many struggle to sustain these improvements over time .
To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants ’ self-management behaviours after attending structured education  and their need for support to sustain improvements in glycaemic control .