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


- candidate number23407
- NTR NumberNTR5515
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2015
- Secondary IDsABR: 53125; METC: 15/438 NL53125.041.15
- Public TitleSelf-management in type 2 diabetes patients on insulin therapy triggered by app-messages
- Scientific TitleSelf-management in type 2 diabetes patients on insulin therapy triggered by app-messages
- ACRONYMTRIGGER study
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Insuline, Selfmanagement
- Inclusion criteriaEligible 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 care. Logistic requirements are the possession of an e-mail address and a smartphone.
- Exclusion criteriaExclusion 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-nov-2015
- planned closingdate30-apr-2018
- Target number of participants228
- InterventionsText-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)
- Primary outcomeThe 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 outcomeSecondary 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).
- TimepointsBaseline, T3 (after 3 months of follow-up), T6 (after 6 months of follow-up) and T9 (after 9 months of follow-up)
- Trial web sitewww.triggerstudie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Anne Meike Boels
- CONTACT for SCIENTIFIC QUERIES Anne Meike Boels
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Sanofi-Aventis
- PublicationsNA
- Brief summaryBackground: 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.
- Main changes (audit trail)7-sept-2016:
INCLUSION CRITERIA NEW
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.

17-12-2015 recruitment of first participant
- RECORD18-nov-2015 - 12-apr-2017


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