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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44809

Enrollment

228

Registered

2015-11-06

Start date

2015-12-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

noninsulin-dependent diabetes mellitus type 2 diabetes mellitus

Interventions

Receiving of app-triggers to support diabetes self-management regarding dietary habits, physical activity, hypoglycaemia, and glucose regulation (including glycaemic variability). The app-triggers a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients who are on insulin treatment since at least 3 months, with a baseline HbA1c level >7% (53 mmol/mol) aged 40-70 years. Logistic requirements are the possession of an e-mail address and a smartphone.

Exclusion criteria

Exclusion criteria: Insulin naïve type 2 diabetes patients, patients with 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 *7% (53 mmol/mol) without hypoglycaemia (plasma glucose	—

Secondary

Measure	Time frame
Change between baseline and 6 months (end of intervention period) in: - Clinical parameters (body weight, BMI, waist circumference, lipid profile, blood pressure, insulin dose, number of hypoglycaemic events, glycaemic variability) - Self-management (SDSQ) - Food habits (FFQ) - Physical activity (IPAQ) - Health status (EQ-5D, SF36) - Diabetes related quality of life (ADDQoL) - Patients satisfaction (DTSQ). The cost-effectiveness of the intervention after 6 months. In the intervention group only: satisfaction with the app; the sustainability of the effect of the intervention with regard to the primary outcome, body weight and EQ-5D, after three months of non-use compared to three months prolonged use, both after six months of initial use of the app; determinants of success for the primary outcome; such as gender, age, social economic status, diabetes duration, short or prolonged intervention.	—

Measure

Time frame

Change between baseline and 6 months (end of intervention period) in: - Clinical parameters (body weight, BMI, waist circumference, lipid profile, blood pressure, insulin dose, number of hypoglycaemic events, glycaemic variability) - Self-management (SDSQ) - Food habits (FFQ) - Physical activity (IPAQ) - Health status (EQ-5D, SF36) - Diabetes related quality of life (ADDQoL) - Patients satisfaction (DTSQ). The cost-effectiveness of the intervention after 6 months. In the intervention group only: satisfaction with the app; the sustainability of the effect of the intervention with regard to the primary outcome, body weight and EQ-5D, after three months of non-use compared to three months prolonged use, both after six months of initial use of the app; determinants of success for the primary outcome; such as gender, age, social economic status, diabetes duration, short or prolonged intervention.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)