The Diabetes Patient Takes Responsibility (DiaTast)

Modulex

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Health Care Economics and Organizations; Patient Reported Outcome

Treatments: Other: Out-patient clinic on demand (patient-initiated); Other: Scheduled out-patient clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT03083899

Diatast

Details and patient eligibility

About

People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.

Full description

This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D) are randomized to two groups: (i) Patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients randomized to the intervention group are not called for at fixed time points. They can arrange visits in the diabetes clinic whenever they feel the need to do so. The have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. Questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24 month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements are evaluated at 24 month.

Enrollment: 357 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy

Exclusion criteria

Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

357 participants in 2 patient groups, including a placebo group

Diatast

Experimental group

Description:

Free patient-initiated use of out-patient services

Treatment:

Other: Out-patient clinic on demand (patient-initiated)

Control

Placebo Comparator group

Description:

Scheduled diabetes control

Treatment:

Other: Scheduled out-patient clinic