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').

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

Julius Symposium 2017 - Boels AM

Patient activation in individuals with type 2 diabetes mellitus: does insulin use make a difference

Zorg op maat voor diabetes mellitus type 2

Inleiding De NHG-Standaard Diabetes mellitus type 2 raadt aan om bij het behandelen van hyperglykemie rekening te houden met leeftijd, diabetesduur en intensiteit van de bestaande behandeling. Ook voor hypertensie en dyslipidemie wordt aangeraden de standaardwaarden voor de behandeldoelen (HbA1c, systolische bloeddruk en LDL-cholesterol) aan te passen aan de individuele patiënt. Wij onderzochten de meerwaarde van deze benadering. Methode We voerden een transversaal observatieonderzoek uit op basis van routinegegevens uit het huisartsinformatiesysteem van Leidsche Rijn Julius Gezondheidscentra. Daarin vergeleken we het percentage patiënten dat de behandeldoelen bereikte op basis van individuele streefwaarden zoals aanbevolen in de NHG-Standaarden, met het percentage dat de – striktere – standaardwaarden wist te halen. Resultaten Van de 890 geanalyseerde patiënten bereikte 31,8% de individuele streefwaarden en 24,8% de standaardwaarden. Van de 70-plussers die naast metformine ook andere bloedglucoseverlagers gebruikten, bereikte 66,4% de individuele streefwaarden en 39,1% de standaardwaarden voor HbA1c. Stelt men de bovengrens voor de systolische bloeddruk bij 80-plussers op 160 in plaats van 140 mmHg, dan is bijna de helft van deze patiënten (45,6%) alsnog te beschouwen als ‘goed ingesteld’. Volgt men de aangepaste criteria uit de NHG-Standaard voor LDL-cholesterol, dan vervalt voor 5,2% van alle patiënten de indicatie voor primaire of secundaire preventie. Conclusie De NHG-Standaarden bieden een simpele en praktische strategie om voor individuele diabetespatiënten behandeldoelen vast te stellen die minder strikt zijn dan de geldende standaardwaarden. Daarmee bespaart men een aanzienlijk deel van de diabetespatiënten de nadelige efecten van een al te strikte regulatie van bloedglucose, bloeddruk en cholesterol

Personalised treatment targets in type 2 diabetes patients : The Dutch approach

AIMS: To compare the proportion of cardiometabolic well-controlled type 2 diabetes mellitus (T2DM) patients according to a clearly defined, simple personalised approach, versus the 'one-size-fits-all' approach. METHODS: Observational study using routine data of primary care type 2 diabetes patients in the Netherlands. The proportions of patients that reach the targets for HbA1c, systolic blood pressure and low-density lipoprotein cholesterol in the two different approaches were compared. RESULTS: Of the 890 patients (54.7% men, mean age 62.7 years), 31.8% were well-controlled according to the individualised approach and 24.8% according to the 'one-size-fits-all' approach. For specific subgroups personalising the treatment led to a 5.2%, 27.3% and 45.6% increase of patients achieving low-density lipoprotein cholesterol, HbA1c and systolic blood pressure goals respectively. CONCLUSIONS: A clearly defined and relatively simple personalised approach leads to a higher proportion of T2DM patients considered as cardiometabolic well-controlled. This approach may especially be beneficial for patients aged ≥70 years on more than metformin monotherapy (HbA1c) and for patients aged ≥80 years (SBP). Precisely these patients are suggested not to benefit from stricter HbA1c or SBP targets, whereas they may experience more adverse effects (e.g. hypoglycaemia, postural hypotension) when a stricter target value is pursued

Diabetes self-management education and support delivered by mobile health (m-health) interventions for adults with type 2 diabetes mellitus

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of diabetes self-management education and support delivered by mobile health interventions in adults with type 2 diabetes mellitus

Personalised treatment targets in type 2 diabetes patients : The Dutch approach

AIMS: To compare the proportion of cardiometabolic well-controlled type 2 diabetes mellitus (T2DM) patients according to a clearly defined, simple personalised approach, versus the 'one-size-fits-all' approach. METHODS: Observational study using routine data of primary care type 2 diabetes patients in the Netherlands. The proportions of patients that reach the targets for HbA1c, systolic blood pressure and low-density lipoprotein cholesterol in the two different approaches were compared. RESULTS: Of the 890 patients (54.7% men, mean age 62.7 years), 31.8% were well-controlled according to the individualised approach and 24.8% according to the 'one-size-fits-all' approach. For specific subgroups personalising the treatment led to a 5.2%, 27.3% and 45.6% increase of patients achieving low-density lipoprotein cholesterol, HbA1c and systolic blood pressure goals respectively. CONCLUSIONS: A clearly defined and relatively simple personalised approach leads to a higher proportion of T2DM patients considered as cardiometabolic well-controlled. This approach may especially be beneficial for patients aged ≥70 years on more than metformin monotherapy (HbA1c) and for patients aged ≥80 years (SBP). Precisely these patients are suggested not to benefit from stricter HbA1c or SBP targets, whereas they may experience more adverse effects (e.g. hypoglycaemia, postural hypotension) when a stricter target value is pursued

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').

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

Diabetes self-management education and support delivered by mobile health (m-health) interventions for adults with type 2 diabetes mellitus

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of diabetes self-management education and support delivered by mobile health interventions in adults with type 2 diabetes mellitus

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: 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 < 3.5 mmol/L (< 63 mg/dL)) is a co-primary outcome. Secondary outcomes are body mass index, waist circumference, insulin dose, lipid profile, blood pressure, number of hypoglycaemic events, glycaemic variability, self-management (SDSCA), food habits (FFQ), physical activity (IPAQ), health status (EQ-5D-5 L, SF36), diabetes-dependent quality of life (ADDQoL), diabetes treatment satisfaction (DTSQ), satisfaction with the app, the cost-effectiveness of the intervention after 3 months, and sustainability of the intervention effect (3 months extra follow-up in intervention group to compare prolonged to discontinued use of the app). We will use the intention-to-treat principle to analyse data. Discussion: Innovative 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)

Effectiveness of diabetes self-management education and support via a smartphone application in insulin-treated patients with type 2 diabetes : Results of a randomized controlled trial (TRIGGER study)

Objective: To investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy. Research design and methods: Open two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c ≤53 mmol/mol (≤7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose. Results: Sixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference -0.93 mmol/mol (-0.08%), 95% CI -4.02 to 2.17 mmol/mol (-0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level ≤7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported. Conclusions: This smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them