scholarly journals Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed. A mixed-method analysis of the barriers to and facilitators of successful diabetes self-management, a health economic analysis, a cluster randomised controlled trial of different models of delivery of an educational intervention and the potential of insulin pumps and additional educator input to improve outcomes

2014 ◽  
Vol 2 (5) ◽  
pp. 1-188 ◽  
Author(s):  
Simon Heller ◽  
Julia Lawton ◽  
Stephanie Amiel ◽  
Debbie Cooke ◽  
Peter Mansell ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Dose Adjustment ◽  
Controlled Trial ◽  
Explanatory Power ◽  
Research Programme ◽  
Self Management ◽  
Randomised Controlled ◽  
The Uk ◽  
Hypoglycaemia Awareness

BackgroundMany adults with type 1 diabetes cannot self-manage their diabetes effectively and die prematurely with diabetic complications as a result of poor glucose control. Following the positive results obtained from a randomised controlled trial (RCT) by the Dose Adjustment For Normal Eating (DAFNE) group, published in 2002, structured training is recommended for all adults with type 1 diabetes in the UK.AimWith evidence that blood glucose control is not always improved or sustained, we sought to determine factors explaining why some patients benefit from training more than other patients, identifying barriers to successful self-management, while developing other models to make skills training more accessible and effective.FindingsWe confirmed that glycaemic outcomes are not always improved or sustained when the DAFNE programme is delivered routinely, although improvements in psychosocial outcomes are maintained. DAFNE courses and follow-up support is needed to help participants instil and habituate key self-management practices such as regular diary/record keeping. DAFNE graduates need structured professional support following training. This is currently either unavailable or provided ad hoc without a supporting evidence base. Demographic and psychosocial characteristics had minimal explanatory power in predicting glycaemic control but good explanatory power in predicting diabetes-specific quality of life over the following year. We developed a DAFNE course delivered for 1 day per week over 5 weeks. There were no major differences in outcomes between this and a standard 1-week DAFNE course; in both arms of a RCT, glycaemic control improved by less than in the original DAFNE trial. We piloted a course delivering both the DAFNE programme and pump training. The pilot demonstrated the feasibility of a full multicentre RCT and resulted in us obtaining subsequent Health Technology Assessment programme funding. In collaboration with the National Institute for Health Research (NIHR) Diabetes Research Programme at King’s College Hospital (RG-PG-0606-1142), London, an intervention for patients with hypoglycaemic problems, DAFNE HART (Dose Adjustment for Normal Eating Hypoglycaemia Awareness Restoration Training), improved impaired hypoglycaemia awareness and is worthy of a formal trial. The health economic work developed a new type 1 diabetes model and confirmed that the DAFNE programme is cost-effective compared with no structured education; indeed, it is cost-saving in the majority of our analyses despite limited glycated haemoglobin benefit. Users made important contributions but this could have been maximised by involving them with grant writing, delaying training until the group was established and funding users’ time off work to maximise attendance. Collecting routine clinical data to conduct continuing evaluated roll-out is possible but to do this effectively requires additional administrator support and/or routine electronic data capture.ConclusionsWe propose that, in future work, we should modify the current DAFNE curricula to incorporate emerging understanding of behaviour change principles to instil and habituate key self-management behaviours that include key DAFNE competencies. An assessment of numeracy, critical for insulin dose adjustment, may help to determine whether or not additional input/support is required both before and after training. Models of structured support involving professionals should be developed and evaluated, incorporating technological interventions to help overcome the barriers identified above and enable participants to build effective self-management behaviours into their everyday lives.Trial registrationClinicalTrials.gov NCT01069393.FundingThe NIHR Programme Grants for Applied Research programme.

scholarly journals Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040438
Author(s):  
Elizabeth Coates ◽  
Stephanie Amiel ◽  
Wendy Baird ◽  
Mohammed Benaissa ◽  
Alan Brennan ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Dose Adjustment ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Self Management ◽  
Glucose Levels ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionThe successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs).Methods and analysisA pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.Ethics and disseminationEthics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.Trial registration numberISRCTN42908016.

scholarly journals Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial

Diabetologia ◽  
2021 ◽  
Author(s):  
Robin Assfalg ◽  
Jan Knoop ◽  
Kristi L. Hoffman ◽  
Markus Pfirrmann ◽  
Jose Maria Zapardiel-Gonzalo ◽  
...  
Keyword(s):  
Immune Response ◽  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Antibody Responses ◽  
Oral Insulin ◽  
Cell Responses ◽  
Randomised Controlled

Abstract Aims/hypothesis Oral administration of antigen can induce immunological tolerance. Insulin is a key autoantigen in childhood type 1 diabetes. Here, oral insulin was given as antigen-specific immunotherapy before the onset of autoimmunity in children from age 6 months to assess its safety and immune response actions on immunity and the gut microbiome. Methods A phase I/II randomised controlled trial was performed in a single clinical study centre in Germany. Participants were 44 islet autoantibody-negative children aged 6 months to 2.99 years who had a first-degree relative with type 1 diabetes and a susceptible HLA DR4-DQ8-containing genotype. Children were randomised 1:1 to daily oral insulin (7.5 mg with dose escalation to 67.5 mg) or placebo for 12 months using a web-based computer system. The primary outcome was immune efficacy pre-specified as induction of antibody or T cell responses to insulin and measured in a central treatment-blinded laboratory. Results Randomisation was performed in 44 children. One child in the placebo group was withdrawn after the first study visit and data from 22 insulin-treated and 21 placebo-treated children were analysed. Oral insulin was well tolerated with no changes in metabolic variables. Immune responses to insulin were observed in children who received both insulin (54.5%) and placebo (66.7%), and the trial did not demonstrate an effect on its primary outcome (p = 0.54). In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03). T cell responses to insulin were modified by treatment-independent inflammatory episodes. Conclusions/interpretation The study demonstrated that oral insulin immunotherapy in young genetically at-risk children was safe, but was not associated with an immune response as predefined in the trial primary outcome. Exploratory analyses suggested that antibody responses to oral insulin may occur in children with a susceptible INS genotype, and that inflammatory episodes may promote the activation of insulin-responsive T cells. Trial registration Clinicaltrials.gov NCT02547519 Funding The main funding source was the German Center for Diabetes Research (DZD e.V.) Graphical abstract

scholarly journals Feasibility study of real-time online text-based CBT to support self-management for people with type 1 diabetes: the Diabetes On-line Therapy (DOT) Study

2021 ◽  
Vol 9 (1) ◽  
pp. e001934
Author(s):  
Anne M Doherty ◽  
Anne Herrmann-Werner ◽  
Arann Rowe ◽  
Jennie Brown ◽  
Scott Weich ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Real Time ◽  
Instant Messaging ◽  
Controlled Trial ◽  
Self Management ◽  
Diabetes Distress ◽  
The Mean ◽  
Distress Scale

IntroductionThis study examines the feasibility of conducting diabetes-focused cognitive–behavioral therapy (CBT) via a secure online real-time instant messaging system intervention to support self-management and improve glycemic control in people with type 1 diabetes.Research design and methodsWe used a pre–post uncontrolled intervention design over 12 months. We recruited adults with type 1 diabetes and suboptimal glycemic control (HbA1c ≥69 mmol/mol (DCCT 8.5%) for 12 months) across four hospitals in London. The intervention comprised 10 sessions of diabetes-focused CBT delivered by diabetes specialist nurses. The primary outcomes were number of eligible patients, rates of recruitment and follow-up, number of sessions completed and SD of the main outcome measure, change in HbA1c over 12 months. We measured the feasibility of collecting secondary outcomes, that is, depression measured using Patient Health Questionnaire-9 (PHQ-9), anxiety measured Generalised Anxiety Disorder (GAD) and the Diabetes Distress Scale (DDS).ResultsWe screened 3177 patients, of whom 638 were potentially eligible, from whom 71 (11.1%) were recruited. The mean age was 28.1 (13.1) years, and the mean HbA1c was 84.6 mmol/mol (17.8), DCCT 9.9%. Forty-six (65%) patients had at least 1 session and 29 (41%) completed all sessions. There was a significant reduction in HbA1c over 12 months (mean difference −6.2 (2.3) mmol/mol, DCCT 0.6%, p=0.038). The change scores in PHQ-9, GAD and DDS also improved.ConclusionsIt would be feasible to conduct a full-scale text-based synchronized real-time diabetes-focused CBT as an efficacy randomized controlled trial.

scholarly journals Cost-effectiveness of home versus hospital management of children at onset of type 1 diabetes: the DECIDE randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e043523
Author(s):  
Zoe McCarroll ◽  
Julia Townson ◽  
Timothy Pickles ◽  
John W Gregory ◽  
Rebecca Playle ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Case Analysis ◽  
Base Case ◽  
Base Case Analysis ◽  
Home Management ◽  
Randomised Controlled

ObjectiveThe aim of this economic evaluation was to assess whether home management could represent a cost-effective strategy in the patient pathway of type 1 diabetes (T1D). This is based on the Delivering Early Care In Diabetes Evaluation trial (ISRCTN78114042), which compared home versus hospital management from diagnosis in childhood diabetes and found no statistically significant difference in glycaemic control at 24 months.DesignCost-effectiveness analysis alongside a randomised controlled trial.SettingEight paediatric diabetes centres in England, Wales and Northern Ireland.Participants203 clinically well children aged under 17 years, with newly diagnosed T1D and their carers.Outcome measuresThe base-case analysis adopted n National Health Service (NHS) perspective. A scenario analysis assessed costs from a broader societal perspective. The incremental cost-effectiveness ratio (ICER), expressed as cost per mmol/mol reduction in glycated haemoglobin (HbA1c), was based on the mean difference in costs between the home and hospital groups, divided by mean differences in effectiveness (HbA1c). Uncertainty was considered in terms of the probability of cost-effectiveness.ResultsAt 24 months postintervention, the base-case analysis showed a difference in costs between home and hospital, in favour of home management (mean difference −£2,217; 95% CI −£2825 to −£1,609; p<0.001). Home care dominated, with an ICER of £7434 (saved) per mmol/mol reduction of HbA1c. The results of the scenario analysis also favoured home management. The greatest driver of cost differences was hospitalisation during the initiation period.ConclusionsHome management from diagnosis of children with T1D who are medically stable represents a less costly approach for the NHS in the UK, without impacting clinical effectiveness.Trial registration numberISRCTN78114042.

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