Self-management in type 2 diabetes patients on insulin therapy triggered by app-messages

Background: Self-management is one of the cornerstones in the treatment of type 2 diabetes mellitus (T2DM) patients, especially in insulin treatment, but difficult to maintain. Health care providers aim to stimulate self-management. However, they have a limited number of patient¡¯s visits in which they can stimulate the patients. With the growing number of T2DM patients innovative and (cost-)effective interventions to promote self-management are needed. We aim to evaluate the (cost-)effectiveness of a smartphone app on self-management in T2DM patients on insulin therapy.


Methods/Design: Non-blinded randomised controlled trial with parallel groups and equal

randomisation. Eligible patients are T2DM patients on insulin therapy since at least three

months with a baseline HbA1c >53 mmol/mol (>7%). In total 330 patients are needed and will

be recruited in general practices and hospitals in the Netherlands. The intervention group (n

= 165) will receive text-messages via a smartphone app aiming to trigger diabetes self-

management. These app-triggers are evidence and psychological theory based, unidirectional,

messages with regard to dietary habits, physical activity, hypoglycaemia and glucose regulation.

Patients choose their preferred frequency and topics of the intervention. The control group (n =

165) will receive standard care. The control group will be a ‘waiting list control group’; when the

study is finished they will get the opportunity to use the intervention. Randomisation takes place

at patient level. Data are obtained during regular diabetes monitoring visits. The primary study

endpoints are 1) the percentage of patients who achieve an HbA1c level <53 mmol/mol

(<7%) without hypoglycaemia (plasma glucose 3.5 mmol/L (63 mg/dL), and 2) the HbA1c

level (continuous variable) after a follow-up of six months. Secondary outcomes are body mass

index, body weight, waist circumference, insulin dose, lipoprotein profile, blood pressure,

number of hypoglycaemic events, glycaemic variability, self-management (SDSQ), food habits

(FFQ), physical activity (IPAQ), health status (EQ-5D, SF36), diabetes-dependent quality of life

(ADDQoL), patient¡¯s satisfaction (DTSQ) and satisfaction with the app; the cost-effectiveness

of the intervention after six months; sustainability of the intervention (three months extra follow-

up). We will use the intention-to- treat principle to analyse our data.

We hypothesize that receiving behavioural triggers, sent as text-messages via a smartphone app, results in increased diabetes self-management of type 2 diabetes patients on insulin therapy, and subsequently to improved glycaemic control, less weight gain and less glucose variability with less hypoglycaemic events.

Baseline, T3 (after 3 months of follow-up), T6 (after 6 months of follow-up) and T9 (after 9 months of follow-up)..

17-12-2015 recruitment of first participant.

Text-messages via a smartphone app aiming to trigger diabetes self-management of type 2 diabetes patients on insulin therapy. These app-triggers are evidence and psychological theory based, unidirectional, messages with regard to dietary habits, physical activity, hypoglycaemia and glucose regulation. Patients choose their preferred frequency and topics of the text message (3 or 4 topics, including at least hypoglycemia)