Dataset Information

Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - design of a randomised controlled trial ('TRIGGER study').

ABSTRACT:

Background

Health care providers aim to stimulate self-management in type 2 diabetes (T2DM) patients. However, they have a limited number of patient contacts to do this. With the growing number of T2DM patients, innovative and cost-effective interventions to promote self-management are needed. We aim to evaluate the effectiveness of diabetes self-management education via a smartphone app in T2DM patients on insulin therapy.

Methods

Non-blinded two-arm multi-centre randomised controlled superiority trial with parallel-groups and equal randomisation ('TRIGGER study'). Eligible patients are 40-70 years, on insulin therapy since at least 3 months, with HbA1c >?53 mmol/mol (>?7%). In total 228 patients will be recruited. The intervention group (n?=?114) will receive diabetes self-management education via a smartphone app to trigger diabetes self-management: unidirectional text messages, free of charge, evidence and psychological theory based, with regard to dietary habits, physical activity, hypoglycaemia and glucose variability. Patients choose their preferred frequency (two to six times per week), topics (two or three additionally to hypoglycaemia, which is an obligatory topic), and duration (6 or 9 months). The control group (n?=?114) will receive care-as-usual. The primary study endpoint is the HbA1c level after a follow-up of 6 months. The percentage of patients who achieve an HbA1c level???53 mmol/mol (?7%) without hypoglycaemia (plasma glucose DiscussionInnovative solutions are needed to improve the (cost-) effectiveness of self-management for the increasing number of T2DM patients. This trial will provide evidence on the effectiveness of a newly developed smartphone app, designed to trigger diabetes self-management.

Trial registration

Dutch Trial Register NTR5515 , registration date: 18 November 2015 (prospectively registered).

SUBMITTER: Boels AM

PROVIDER: S-EPMC6196442 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - design of a randomised controlled trial ('TRIGGER study').

Boels Anne Meike AM Rutten Guy G Zuithoff Nicolaas N de Wit Ardine A Vos Rimke R

BMC endocrine disorders 20181022 1

<h4>Background</h4>Health care providers aim to stimulate self-management in type 2 diabetes (T2DM) patients. However, they have a limited number of patient contacts to do this. With the growing number of T2DM patients, innovative and cost-effective interventions to promote self-management are needed. We aim to evaluate the effectiveness of diabetes self-management education via a smartphone app in T2DM patients on insulin therapy.<h4>Methods</h4>Non-blinded two-arm multi-centre randomised contr ...[more]

PMID: 30348142

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Project description:BACKGROUND:Diabetes poses heavy economic and social burdens worldwide. Mobile apps show great potential for diabetes self-management education. However, there is limited evidence for the effectiveness of providing general diabetes education through mobile apps. OBJECTIVE:The aim of this study was to clarify the effectiveness of Lilly Connected Care Program (LCCP) app-based diabetes education for glycemic control. METHODS:This retrospective cohort study included patients with diabetes recruited to the LCCP platform from September 1, 2018, to May 31, 2019. Each patient was followed for 12 weeks. According to the number of diabetes education courses they had completed, the patients were divided into the following three groups: group A (0-4 courses), group B (5-29 courses), and group C (?30 courses). The main outcomes were the change in blood glucose at the 12th week compared with baseline and the differences in blood glucose at the 12th week among the three groups. The associations of the number of diabetes education courses completed with the average blood glucose and frequency of self-monitoring of blood glucose (SMBG) at the 12th week were assessed by multivariate linear regression analyses controlling for other confounding covariates. Univariate and multivariate linear regression analyses were used to assess factors influencing patients' engagement in the diabetes education courses. RESULTS:A total of 5011 participants were enrolled. Their mean fasting blood glucose (FBG) and postprandial blood glucose (PBG) were significantly lower at the 12th week than at baseline (FBG, 7.46 [standard deviation (SD) 1.95] vs 7.79 [SD 2.18] mmol/L, P<.001; PBG, 8.94 [SD 2.74] vs 9.53 [SD 2.81] mmol/L, P<.001). The groups that completed more diabetes education courses had lower FBG (group B, ?=-0.14, 95% CI -0.26 to -0.03; group C, ?=-0.29, 95% CI -0.41 to -0.16; P for trend <.001) and PBG (group B, ?=-0.29, 95% CI -0.46 to -0.11; group C, ?=-0.47, 95% CI -0.66 to -0.28; P for trend <.001) and a higher frequency of SMBG at the 12th week (group B, ?=1.17, 95% CI 0.81-1.53; group C, ?=4.21, 95% CI 3.81-4.62; P for trend <.001) when compared with the findings in group A. Age and education were related to patients' engagement in the diabetes education courses. Middle-aged patients (35-59 years old) and elderly patients (?60 years old) completed more diabetes education courses (middle-aged group, ?=2.22, P=.01; elderly group, ?=2.42, P=.02) than young patients (18-34 years old). CONCLUSIONS:LCCP app-based diabetes education is effective for glycemic control and SMBG behavior improvement in patients with type 2 diabetes receiving insulin therapy. Young patients' engagement in the education courses was relatively low. We need to conduct in-depth interviews with users to further improve the curriculum.

Project description:BACKGROUND AND OBJECTIVE: The guidelines of the German College of General Practitioners and Family Physicians (DEGAM) on frequent and important reasons for encounter in Primary Care play a central role in the teaching of Family Medicine. They were edited by the authors into an app for mobile phones, making them available at all times to General Practitioners and medical students. This study examines the issue: how useful do students consider this application within their learning process in Family Medicine? METHOD: The short versions of the 15 DEGAM guidelines were processed as a web app (for all smartphone software systems) including offline utilisation, and offered to students in the Family Medicine course, during clinical attachments in General Practice, on elective compulsory courses or for their final year rotation in General Practice. The evaluation was made with a structured survey using the feedback function of the Moodle learning management system [http://www.elearning-allgemeinmedizin.de] with Likert scales and free-text comments. RESULTS: Feedback for evaluation came from 14 (25%) of the student testers from the Family Medicine course (9), the clinical attachment in General Practice (1), the final year rotation in General Practice (1) and elective compulsory courses (4). Students rated the app as an additional benefit to the printed/pdf-form. They use it frequently and successfully during waiting periods and before, during, or after lectures. In addition to general interest and a desire to become acquainted with the guidelines and to learn, the app is consulted with regard to general (theoretical) questions, rather than in connection with contact with patients. Interest in and knowledge of the guidelines is stimulated by the app, and on the whole the application can be said to be well suited to the needs of this user group. DISCUSSION: The students evaluated the guidelines app positively: as a modern way of familiarising them with the guidelines and expanding their knowledge, particularly through its use in waiting periods and the attractive medium smartphone. However, the latter prevents a mandatory curricular use in compulsory courses, since not all students use smartphones. It is a meaningful addition to existing teaching materials and supports evidence-based teaching in Family Medicine and is suitable for use not only in university course teaching but also during clinical training.

Project description:OBJECTIVE:To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet. DESIGN:A multicentre, non-blinded randomised controlled trial. SETTING:Five diabetes outpatient clinics in the Oslo region. PARTICIPANTS:Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum. INTERVENTION:The Pregnant+ app and usual care, the control group received usual care. PRIMARY AND SECONDARY OUTCOMES:The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported. RESULTS:No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered. CONCLUSION:The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant. TRIAL REGISTRATION NUMBER:NCT02588729.

Project description:OBJECTIVES:To assess the long-term cost-effectiveness of insulin pumps and Dose Adjustment for Normal Eating (pumps+DAFNE) compared with multiple daily insulin injections and DAFNE (MDI+DAFNE) for adults with type 1 diabetes mellitus (T1DM) in the UK. METHODS:We undertook a cost-utility analysis using the Sheffield Type 1 Diabetes Policy Model and data from the Relative Effectiveness of Pumps over Structured Education (REPOSE) trial to estimate the lifetime incidence of diabetic complications, intervention-based resource use and associated effects on costs and quality-adjusted life years (QALYs). All economic analyses took a National Health Service and personal social services perspective and discounted costs and QALYs at 3.5% per annum. A probabilistic sensitivity analysis was performed on the base case. Further uncertainties in the cost of pumps and the evidence used to inform the model were explored using scenario analyses. SETTING:Eight diabetes centres in England and Scotland. PARTICIPANTS:Adults with T1DM who were eligible to receive a structured education course and did not have a strong clinical indication or a preference for a pump. INTERVENTION:Pumps+DAFNE. COMPARATOR:MDI+DAFNE. MAIN OUTCOME MEASURES:Incremental costs, incremental QALYs gained and incremental cost-effectiveness ratios (ICERs). RESULTS:Compared with MDI+DAFNE, pumps+DAFNE was associated with an incremental discounted lifetime cost of +£18?853 (95% CI £6175 to £31 645) and a gain in discounted lifetime QALYs of +0.13 (95% CI -0.70 to +0.96). The base case mean ICER was £142?195 per QALY gained. The probability of pump+DAFNE being cost-effective using a cost-effectiveness threshold of £20?000 per QALY gained was 14.0%. All scenario and subgroup analyses examined indicated that the ICER was unlikely to fall below £30?000 per QALY gained. CONCLUSIONS:Our analysis of the REPOSE data suggests that routine use of pumps in adults without an immediate clinical need for a pump, as identified by National Institute for Health and Care Excellence, would not be cost-effective. TRIAL REGISTRATION NUMBER:ISRCTN61215213.

Dataset Information

Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - design of a randomised controlled trial ('TRIGGER study').

Background

Methods

Trial registration

Publications

Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - design of a randomised controlled trial ('TRIGGER study').

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