Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial Patients' education, and its impact on care outcomes, resource consumption and working conditions: data from the International Diabetes Management Practices Study (IDMPS). Effects of a Family-based Diabetes Intervention on Behavioral and Biological Outcomes for Mexican American Adults The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial The effectiveness of case management for comorbid diabetes type 2 patients; the CasCo study. Design of a randomized controlled trial A culturally competent intervention of education and care for black women with type 2 diabetes. A culturally targeted self-management program for African Americans with type 2 diabetes mellitus. Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model. Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol HeLP-Diabetes: randomised controlled trial protocol Efficacy of self-monitoring blood glucose as a key component of a chronic care model versus usual care in type 2 diabetes patients treated with oral agents: results of a randomized trial Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Efficacy of a self-management education program for people with type 2 diabetes: results of a 12 month trial. The relative effectiveness of self-management programs for type 2 diabetes. Effects of an Outpatient Diabetes Self-Management Education on Patients with Type 2 Diabetes in China: A Randomized Controlled Trial Rationale and design: telephone-delivered behavioral skills interventions for Blacks with type 2 diabetes Making sense of change: patients' views of diabetes and GP-led integrated diabetes care.
Background Diabetes specific emotional problems interfere with the dem and ing daily management of living with type 2 diabetes mellitus ( T2DM ) . Possibly , offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients ' belief they are able to manage their illness . It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy . Methods and design Six hundred patients with T2DM ( 45 ≤ 75 years ) who receive care in a structured diabetes care system , HbA1c ≥ 7.0 % , and not using insulin  will be recruited and r and omized into 3 groups ; Self-monitoring of Blood Glucose ( SMBG ) , Self-monitoring of Urine Glucose ( SMUG ) and usual care ( n = 200 per group ) . Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year . All 3 groups will receive st and ardized diabetes care . The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results . Main outcome measures are changes in diabetes specific emotional distress and self-efficacy . Secondary outcome measures include difference in HbA1c , patient satisfaction , occurrence of hypoglycaemia , physical activity , costs of direct and indirect healthcare and changes in illness beliefs . Discussion The IN CONTROL-trial is design ed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy . Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions , guiding the patient to reduce emotional responses to experienced threats , and influences the patients ability to perform and maintain self-management skills . Trial registration Current Controlled Trials IS RCT AIM To evaluate the impact of diabetes education provided to patients with type 2 diabetes mellitus ( T2DM ) in non-controlled studies ( " real-world conditions " ) on quality of care , re source consumption and conditions of employment . METHODS This cross-sectional study and longitudinal follow-up describe the data ( demographic and socioeconomic profiles , clinical characteristics , treatment of hyperglycaemia and associated cardiovascular risk factors , re source consumption ) collected during the second phase ( 2006 ) of the International Diabetes Management Practice s Study ( IDMPS ) . Patients received diabetes education directly from the practice nurse , dietitian or educator , or were referred to ad hoc group-education programmes ; all programmes emphasized healthy lifestyle changes , self-care and active participation in disease control and treatment . Educated vs non-educated T2DM patients ( n=5692 in each group ) , paired by age , gender and diabetes duration , were r and omly recruited for the IDMPS by participating primary -care physicians from 27 countries in Eastern Europe , Asia , Latin America and Africa . Outcome measures included clinical ( body weight , height , waist circumference , blood pressure , foot evaluation ) , metabolic ( HbA(1c ) levels , blood lipid profile ) and biochemical control measures . Treatment goals were defined according to American Diabetes Association guidelines . RESULTS T2DM patients ' education significantly improved the percentage of patients achieving target values set by international guidelines . Educated patients increased their insulin use and self-care performance , had a lower rate of chronic complications and a modest increase in cost of care , and probably higher salaries and slightly better productivity . CONCLUSION Diabetes education is an efficient tool for improving care outcomes without having a major impact on healthcare costs Purpose The purpose of the study was to investigate the effects of a family-based self-management support intervention for adults with type 2 diabetes ( T2DM ) . Methods Using a 2-group , experimental repeated measures design , 157 dyads ( participant with T2DM and family member ) were r and omly assigned to an intervention ( education , social support , home visits , and telephone calls ) or a wait list control group . Data were collected at baseline , postintervention ( 3 months ) , and 6 months postintervention . A series of 2 × 3 repeated measures ANOVAs were used to test the hypotheses with interaction contrasts to assess immediate and sustained intervention effects . Results Significant changes over time were reported in diet self-management , exercise self-management , total self-management , diabetes self-efficacy for general health and total diabetes self-efficacy , physician distress , regimen distress , interpersonal distress , and total distress . There were likewise sustained effects for diet self-management , total self-management , diabetes self-efficacy for general health , total self-efficacy , physician distress , regimen distress , and interpersonal distress . Conclusions Results support and extend prior research documenting the value of culturally relevant family-based interventions to improve diabetes self-management and substantiate the need for intensive , longer , tailored interventions to achieve glycemic control Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Background More than half of the patients with type 2 diabetes ( T2DM ) patients are diagnosed with one or more comorbid disorders . They can participate in several single-disease oriented disease management programs , which may lead to fragmented care because these programs are not well prepared for coordinating care between programs . Comorbid patients are therefore at risk for suboptimal treatment , unsafe care , inefficient use of health care services and unnecessary costs . Case management is a possible model to counteract fragmented care for comorbid patients . It includes evidence -based optimal care , but is tailored to the individual patients ' preferences . The objective of this study is to examine the effectiveness of a  case management program , in addition to a diabetes management program , on the quality of care for comorbid T2DM patients . Methods / Design The study is a r and omized controlled trial among patients with T2DM and at least one comorbid chronic disease ( N = 230 ) , who already participate in a diabetes management program .  R and omization will take place at the level of the patients in general practice s. Trained practice nurses ( case managers ) will apply a case management program in addition to the diabetes management program . The case management intervention is based on the Guided Care model and includes six elements ; assessing health care needs , planning care , create access to other care providers and community re sources , monitoring , coordinating care and recording of all relevant information . Patients in the control group will continue their participation in the diabetes management program and receive care-as-usual from their general practitioner and other care providers . Discussion We expect that the case management program , which includes better structured care based on scientific evidence and adjusted to the patients ' needs and priorities , will improve the quality of care coordination from both the patients ' and caregivers ' perspective and will result in less consumption of health care services . Trial registration Netherl and s Trial Register ( NTR ) : This article reports on the development and pilot feasibility testing of a culturally competent intervention of education and care for black women with type 2 diabetes mellitus ( T2DM ) . Using a one group , pretest posttest quasi-experimental design , the intervention was tested with a convenience sample of 25 community black women with T2DM . The conceptual basis , process , and content of the intervention as well as the feasibility and acceptability of study material s and methods are described . Significant improvements from baseline to 3 months were observed in measures of glycemic control , weight , body mass index , and diabetes-related emotional distress . The findings suggest that a culturally sensitive intervention of nurse practitioner diabetes care and education is beneficial for black women with T2DM , result ing in program attendance , kept appointments , improved glycemic control and weight , and decreased diabetes-related emotional distress Inadequate knowledge of the influence of lifestyle on clinical outcomes contributes to the difficulties many African Americans experience with type 2 diabetes mellitus ( T2DM ) . This pilot study examined a 12-week church-based culturally targeted diabetes self-management education ( DSME ) intervention for middle-aged and older African Americans with T2DM . Quantitative data were collected at baseline and at 12 weeks and included question naires and anthropometric measures . There were significant increases in medication adherence ( p = .006 ) , healthy eating ( p = .009 ) , and foot care adherence ( p = .003 ) . The intervention had a clinical ly significant effect on systolic blood pressure , blood lipids , physical activity , and waist circumference . Church-based culturally targeted DSME interventions may result in improved outcomes for African-American adults with T2DM . The authors discuss the value of community-based interventions that target behavioural changes in population s of chronically ill patients , particularly those who historically have been disenfranchised and /or underserved OBJECTIVE This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs ( DSMP ) . We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization . METHODS Electronic medical records ( EMR ) were obtained for 376 adults enrolled in a r and omized controlled trial ( RCT ) of Type 2 diabetes ( T2DM ) self-management programs . All study participants had uncontrolled diabetes and were r and omized into either : personal digital assistant ( PDA ) , Chronic Disease Self-Management Program ( CDSMP ) , combined PDA and CDSMP ( COM ) , or usual care ( UC ) groups . Subjects were followed for a maximum of two years . Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization . RESULTS Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization ( Hazard ratio : 0.10 ; p=0.002 ) when compared to subjects in the control arm . Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm . CONCLUSION CDSMP can be effective in delaying time-to-hospitalization among patients with T2DM . PRACTICE IMPLICATION S Reducing unnecessary healthcare utilization , particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs . The CDSMP offers the potential to reduce time-to-hospitalization among T2DM patients Background Patients with type 2 diabetes mellitus ( T2DM ) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control . While self-monitoring of blood glucose ( SMBG ) has proven to be effective for those treated with insulin , it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification . We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor , underst and the impact of lifestyle behaviors on glycemic control , and adjust their self-care based on context ualized SMBG data . Objective The primary objective of this r and omized controlled trial ( RCT ) is to determine the impact of bant2 , an evidence -based , patient-centered , behavioral mobile app intervention , on the self-management of T2DM . Our second postulation is that automated feedback delivered through the mobile app will be as effective , less re source intensive , and more scalable than interventions involving additional health care provider feedback . Methods This study is a 12-month , prospect i ve , multicenter RCT in which 150 participants will be r and omly assigned to one of two groups : the control group will receive current st and ard of care , and the intervention group will receive the mobile phone app system in addition to st and ard of care . The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months . Results The first patient was enrolled on July 28 , 2015 , and we anticipate completing this study by September , 2018 . Conclusions This RCT is one of the first to evaluate an evidence -based mobile app that focuses on facilitating lifestyle behavior change driven by context ualized and structured SMBG . The results of this trial will provide insights regarding the usage of mobile tools and consumer- grade devices for diabetes self-care , the economic model of using incentives to motivate behavior change , and the consumption of test strips when following a rigorously structured approach for SMBG . Trial Registration Clinical Trials.gov NCT02370719 ; https:// clinical trials.gov/ct2/show/NCT02370719 ( Archived at http://www.webcitation.org/6jpyjfVRs Background Type 2 Diabetes Mellitus ( T2DM ) is common , affecting nearly 400 million people worldwide . Achieving good health for people with T2DM requires active self-management ; however , uptake of self-management education is poor , and there is an urgent need to find better , more acceptable , cost-effective methods of providing self-management support . Web-based self-management support has many potential benefits for patients and health services . The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM . Methods This will be a multi-centre individually r and omised controlled trial in primary care , recruiting adults with T2DM who are registered with participating general practice s in Engl and . Participants will be r and omised to receive either an evidence -based , theoretically informed , web-based self-management programme for people with T2DM which addresses medical , emotional , and role management , called Healthy Living for People with type 2 Diabetes ( HeLP-Diabetes ) or a simple information website . The joint primary outcomes are glycated haemoglobin ( HbA1c ) and diabetes-related distress , measured by the Problem Areas In Diabetes ( PAID ) question naire . Secondary outcomes include cardiovascular risk factors , depression and anxiety , and self-efficacy for self-management of diabetes . Health economic data include health service use , costs due to the intervention , and EQ-5D for calculation of Quality Adjusted Life Years ( QALYS ) . Data will be collected at baseline , 3 months and 12 months , with the primary endpoint at 12 months . Practice nurses , blinded to patient allocation , collect clinical data ; patients complete online question naires for patient reported measures . A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c ( both small effect sizes ) . The analysis will follow a pre-specified analysis plan , based on comparing the groups as r and omised ( intention-to-treat ) . Discussion The findings of this trial are likely to be of interest to policy makers , clinicians , and commissioners , all of whom are actively seeking additional forms of self-management support for people with T2DM.Trial registration The Trial Registration number is IS RCT N02123133 ; date of registration 14.2.13 In recent years , patient-centered chronic care models ( CCMs ) have been widely recognized as the most effective approach for the management of chronic diseases including type 2 diabetes ( T2DM ) [ 1 ] ; however , their implementation in the real world is a dem and ing challenge [ 2 , 3 ] . In Italy , the SINERGIA CCM was developed in the diabetes outpatient clinic of Cusano Milanino [ 4 ] . In this model , self-monitoring blood glucose ( SMBG ) represents the key tool for patient engagement ; within the empowerment philosophy , patients undergo an educational process , which incorporates interactive teaching strategies design ed to involve patients in problem-solving and address their clinical , cultural and psychosocial needs [ 5 ] . Patients are actively involved in the discussion of their goals and instructed about the importance of glycemic control , lifestyle modifications , reduction in body weight and regular monitoring of diabetes complications and their risk factors . Organizational aspects , i.e. , training , skills and roles of each member of diabetes team , electronic data collection , and continuity of communication with the patients are also addressed by the model [ 4 ] . Following a preliminary evaluation of the SINERGIA impact in an observational cohort of over 1000 patients with T2DM cared for by the Cusano Milanino center [ 4 ] , the Self-Care Study was design ed as a multicenter , national , r and omized ( 1:1 ) , open-label , parallel group , controlled clinical trial of a duration of 12 months to compare SINERGIA models versus usual care . The primary end point was the change after 12 months from r and omization in HbA1c levels . Secondary end points were changes in body weight , waist circumference , blood pressure , lipid profile , specific quality -of-life scores , incidence of hypoglycemia and adverse events , and contacts between patient and center . After 24 months from r and omization , an additional analysis ( post-trial observational phase of the study ) assessed the long-term impact of SINERGIA versus  usual care . Inclusion criteria were : men or women aged ≥ 45 years with diagnosis of T2DM , at their first access at the diabetes clinic , with any diabetes duration , HbA1c > 7.0 and ≤ 9.0 % , treated or requiring the initiation of therapy with any oral oral hypoglycemic agent ( OHA ) , not using SMBG ( i.e. , frequency ≤ 1 test/week ) and signature of informed consent . Exclusion criteria were : treated or requiring the initiation of therapy with insulin , any condition that could render the subject unlikely or unable to comply with the protocol requirements ( full list of eligibility criteria available in https:// clinical trials.gov/ct2/show/NCT02082028?term= SINERGIA&cond = Diabetes+Mellitus%2C+Type+2&cntr y1=EU%3AIT&rank=1 ) . Patients were r and omized to two study arms :  patients allocated to the  experimental group received the SINERGIA diabetes educational model [ 4 ] and patients allocated to the control group received the st and ard diabetes education provided by the center , and SMBG ( any glucose meter ) was prescribed only if deemed appropriate based on physician ’s judgment . Patients in both groups were seen six times during the study period : 2 weeks before r and omization , at r and omization visit , 3 , 6 and 12 months after r and omization and 24 months after r and omization ( post-trial ) . Considering as clinical ly relevant a minimum betweengroup difference in HbA1c levels of 0.4 % after 12 months and assuming a st and ard deviation of HbA1c of 0.9 % and a Managed by Antonio Secchi BACKGROUND Ongoing self-management improves outcomes for those with Type 2 diabetes ( T2D ) ; however , there are many barriers to patients receiving assistance in this from the healthcare system and peers . Findings from our pilot study showed that a virtual diabetes community on the Internet with real-time interaction among peers with T2D- and with healthcare professionals-is feasible and has the potential to influence clinical and psychosocial outcomes . OBJECTIVE The purpose of this article is to present the protocol for the Diabetes Learning in Virtual Environments ( LIVE ) trial . PROTOCOL Diabetes LIVE is a two-group , r and omized controlled trial to compare effects of a virtual environment and traditional Web site on diet and physical activity . Our secondary aims will determine the effects on metabolic outcomes ; effects of level of engagement and social network formation in LIVE on behavioral outcomes ; potential mediating effects of changes in self-efficacy ; and diabetes knowledge , diabetes-related distress , and social support on behavior change and metabolic outcomes . We will enroll 300 subjects at two sites ( Duke University/Raleigh-Durham , NC and New York University/New York , NY ) who have T2D and do not have serious complications or comorbidities . Those r and omly assigned to the intervention group have access to the LIVE site where they can find information , synchronous classes with diabetes educators , and peer support to enhance self-management . Those in the control group have access to the same informational and educational content in a traditional asynchronous Web format . Measures of self-management , clinical outcomes , and psychosocial outcomes are assessed at baseline and 3 , 6 , 12 , and 18 months . DISCUSSION Should LIVE prove effective in improved self-management of diabetes , similar interventions could be applied to other prevalent chronic diseases . Innovative programs such as LIVE have potential for improving healthcare access in an easily disseminated alternative model of care that potentially improves the reach of self-management training and support AIM Patient education that enhances one 's self-management ability is of utmost importance for improving patient outcomes in chronic diseases . We developed a 12 month self-management education program for type 2 diabetes , based on a previous 6 month program , and examined its efficacy . METHODS A r and omized controlled trial was carried out on out patients with type 2 diabetes from two hospitals who met the criteria and gave consent to participate . They were r and omly divided into an intervention group that followed the program and a control group that followed usual clinical practise . The intervention group received < 30 min of monthly interviews based on the program 's textbook and biweekly telephone calls from a nurse educator throughout the 12 months . RESULTS Of the 50 participants in the intervention group and the 25 participants in the control group , 42 and 23 , respectively , completed the program ( a completion rate of 84.0 % ) . The body weight , HbA1c , self-efficacy , dietary and exercise stages , quality of life , diastolic blood pressure , and total cholesterol level were significant by two-way repeated- measures anova . As for changes over time within the groups , only the intervention group showed significant differences by Friedman 's test . The complication prevention behaviors showed a high implementation rate in the intervention group . The overall evaluation of this program by the participants was very high and , therefore , they highly recognized the need for this type of program . CONCLUSIONS Self-management education works successfully in relation to patients ' behavior modification skills , degree of goal attainment , and self-efficacy , consequently improving their health outcomes OBJECTIVES The objectives of the study were to investigate the effectiveness of 2 types of peer-led self-management programs in bringing about improvements in subjects with type 2 diabetes mellitus and to determine whether there were differences in effectiveness between the 2 programs . METHODS The study used a 3-arm r and omized controlled trial design with clinical measures taken at baseline and at 6 and 12 months post-program . In total , 405 persons completed baseline question naires and were r and omly allocated to a diabetes self-management program ( n=130 ) , to a general self-management program ( n=109 ) or to a control group ( n=122 ) . A 2-way factorial analyses of variance was employed as the primary statistical analysis . RESULTS The findings showed that the self-management programs had affected 5 of the 30 measures : fatigue , cognitive symptom management , self-efficacy with regard to the disease in general , communication with physician , and the score on the Diabetes Empowerment Scale . In addition , 3 variables-social role limitations , total hospital nights and glycated hemoglobin levels-showed marginally significant interaction effects . The second analysis found similar results , with 4 of the 5 measures remaining statistically significant : fatigue , cognitive symptom management , communication with physician and diabetes empowerment , with neither program being more effective than the other . CONCLUSIONS The major findings are that although both programs were effective in bringing about positive changes in the outcome measures , there was little difference in effectiveness between the Diabetes Self-Management Program and the Chronic Disease Self-Management Program . This finding is consistent with the principle that behaviour-change strategies using self-efficacy are key components in health education programs Objective This study is aim ed at assessing the effectiveness of a simple outpatient diabetes self-management education programme . Methods In the study , 60 patients with type 2 diabetes mellitus were r and omly allocated into the control group ( n = 30 ) and intervention group ( n = 30 ) . Regular and 2-session health education programmes were provided . The summary of diabetes self-care activity measure , problem areas in the diabetes scale , fasting blood glucose , postpr and ial 2 h blood glucose , and HbA1c were measured before and after the intervention to assess the effects of this 2-session diabetes education programme . Results The total mean score of the summary of diabetes self-care activities measure was 17.60 ± 6.63 points . The problem areas in the diabetes scale revealed that the total mean score was 29.82 ± 15.22 points ; 27 % of the patients had diabetes-related distress , while 9 % suffered from severe emotional distress . Compared with the control group , scores of the summary of diabetes self-care activities measure and problem areas in the diabetes scale , fasting blood glucose , postpr and ial 2 h blood glucose , and HbA1c were significantly improved in the intervention group after the intervention ( P < 0.01 ) . Conclusion This study showed that the 2-session diabetes education programme could effectively improve the level of self-reported self-management , psychological distress , and glycemic control in patients with type 2 diabetes mellitus Background African Americans with Type 2 diabetes ( T2DM ) have higher prevalence of diabetes , poorer metabolic control , and greater risk for complications and death compared to American Whites . Poor outcomes in African Americans with T2DM can be attributed to patient , provider , and health systems level factors . Provider and health system factors account for < 10 % of variance in major diabetes outcomes including hemoglobin A1c ( HbA1c ) , lipid control , and re source use . Key differences appear to be at the patient level . Of the patient level factors , consistent differences between African Americans and American Whites with T2DM have been found in diabetes knowledge , self-management skills , empowerment , and perceived control . A variety of interventions to improve diabetes self-management have been tested including : 1 ) knowledge interventions ; 2 ) lifestyle interventions ; 3 ) skills training interventions ; and 4 ) patient activation and empowerment interventions . Most of these interventions have been tested individually , but rarely have they been tested in combination , especially among African Americans who have the greatest burden of diabetes related complications . This study provides a unique opportunity to address this gap in the literature . Methods / Design We describe an ongoing four-year r and omized clinical trial , using a 2 × 2 factorial design , which will test the efficacy of separate and combined telephone-delivered , diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM ( HbA1c ≥ 9 % ) . Two-hundred thirty-two ( 232 ) male and female African-American participants , 18 years of age or older and with an HbA1c ≥ 9 % , will be r and omized into one of four groups for 12-weeks of phone interventions : ( 1 ) an education group , ( 2 ) a motivation/skills group , ( 3 ) a combined group or ( 4 ) a usual care/general health education group . Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control . Our primary hypothesis is that among African Americans with poorly controlled T2DM , patients r and omized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group . Discussion Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM.Trial registration National Institutes of Health Clinical Trials Registry ( Clinical Trials.gov identifier # NCT00929838 ) BACKGROUND Health system reform is directed towards better management of diabetes . However , change can be difficult , and patients ' perspectives are a key aspect of implementing change . OBJECTIVE This study investigated patients ' perceptions and experiences  of  type 2 diabetes ( T2DM )  , self-care and engagement with GP-led integrated diabetes care . DESIGN Qualitative interviews were conducted with purposively selected patients with T2DM following their initial medical appointment in the new model of care .  Normalization process theory was used to orientate the thematic analysis , to explain the work of implementing change . SETTING Two specialist GP-based complex diabetes services in primary care in Brisbane , Australia . PARTICIPANTS Intervention group patients ( n = 30 ) in a r and omized controlled trial to evaluate a model of GP-led integrated care for complex T2DM . MAIN OUTCOME MEASURES Participants ' experiences and perceptions of diabetes management and a GP-led model  of care . RESULTS Three themes were identified : sensibility of change , ' diabetic life ' and diabetes care alliance . The imperative of change made sense , but some participants experienced dissonance between this rational view and their lived reality . Diabetes invaded life , revealing incongruities between participants ' values and living with diabetes . They appreciated a flexible and personalized approach to care . DISCUSSION Participants responded to advice in ways that seemed rational within the complexities of their life context . Their diabetes partnerships with health professionals coupled providers ' biomedical expertise with patients ' context ual expertise . CONCLUSIONS Learning to manage relationships with various health professionals adds to patients ' diabetes-related work . Providers need to adopt a flexible , interactive approach and foster trust , to enable better diabetes care
The pooled main outcomes by r and om-effects model showed significant improvements in HbA1c , self-efficacy , and diabetes knowledge , but not in BMI .
As for quality of life , no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded .
No significant publication bias was found in the main outcomes .
AIM To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes ( T2DM ) in r and omized controlled trials .
BACKGROUND Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients .
Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients .