type 2 diabetes mellitus, eHealth, mHealth, self-management, behavioural change, insulin therapy
Conditions
Interventions
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, unidirecti
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: Eligible participants are type 2 diabetes patients on insulin treatment since at least three months, with a baseline HbA1c >53 mmol/mol (>7%) with no upper limit, aged 40-70 years and treated for their diabetes in primary or secondary care. Logistic requirements are the possession of an e-mail address and a smartphone.
Exclusion criteria
Exclusion criteria: Exclusion criteria are a history of alcoholism, drug abuse, dementia or major psychiatric disorder that is likely to invalidate informed consent or limit the ability of the individual to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactAnne Meike Boels
Universitair Medisch Centrum Utrecht, divisie Julius Centrum
Outcome results
None listed