Self-management in type 2 diabetes patients on insulin therapy triggered by app-messages
Recruiting
- Conditions
- type 2 diabetes mellitus, eHealth, mHealth, self-management, behavioural change, insulin therapy
- Registration Number
- NL-OMON23768
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 228
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).