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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diatast | Experimental | Free patient-initiated use of out-patient services |
|
| Control | Placebo Comparator | Scheduled diabetes control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Out-patient clinic on demand (patient-initiated) | Other | Free use of any resources in the out-patient clinic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome | Questionnaire regarding satisfaction of the out-patient clinic | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical diabetes variables 1 | HbA1c | 24 month |
| Health Care Economy | Use of resources in the out-patient clinic | 24 month |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Claus B Juhl, MD PhD | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of South West Jutland, University hospital of Southern Denmark | Esbjerg | 6700 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Scheduled out-patient clinic | Other | Scheduled use of the out-patient clinic |
|
| Clinical diabetes variables 2 | Blood pressure | 24 month |
| Clinical diabetes variables 3 | Lipids | 24 month |
| Diabetes Dependent quality of Life | Questionnaire | 24 month |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |