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OpenTrials
Completed

NCT Number: NCT03083899

The Diabetes Patient Takes Responsibility

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Care Economics and Organizations Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Patient Reported Outcome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of South West Jutland, University hospital of Southern Denmark

Esbjerg, 6700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Out-patient clinic on demand (patient-initiated)

Other

Free use of any resources in the out-patient clinic

Scheduled out-patient clinic

Other

Scheduled use of the out-patient clinic

Primary outcomes

  1. Patient reported outcome

    Time frame: 24 month

    Questionnaire regarding satisfaction of the out-patient clinic

Secondary outcomes

  1. Clinical diabetes variables 1

    Time frame: 24 month

    HbA1c

  2. Health Care Economy

    Time frame: 24 month

    Use of resources in the out-patient clinic

  3. Clinical diabetes variables 2

    Time frame: 24 month

    Blood pressure

  4. Clinical diabetes variables 3

    Time frame: 24 month

    Lipids

  5. Diabetes Dependent quality of Life

    Time frame: 24 month

    Questionnaire

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Official study title

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

Acronym: DiaTast

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2017
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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