The Diabetes Patient Takes Responsibility

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits

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

Intervention / Treatment
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* Other: Out-patient clinic on demand (patient-initiated)
* Other: Scheduled out-patient clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diatast<br>Free patient-initiated use of out-patient services | Other: Out-patient clinic on demand (patient-initiated)<br>* Free use of any resources in the out-patient clinic<br>|
| Placebo Comparator: Control<br>Scheduled diabetes control | Other: Scheduled out-patient clinic<br>* Scheduled use of the out-patient clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome | Questionnaire regarding satisfaction of the out-patient clinic | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical diabetes variables 1 | HbA1c | 24 month | 
| Health Care Economy | Use of resources in the out-patient clinic | 24 month | 
| Clinical diabetes variables 2 | Blood pressure | 24 month | 
| Clinical diabetes variables 3 | Lipids | 24 month | 
| Diabetes Dependent quality of Life | Questionnaire | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Organization, Out-patient control