The Diabetes Patient Takes Responsibility

Diabetes Mellitus, Type 1 Clinical Trial

— DiaTast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083899
• Other study ID #: Diatast
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 22, 2019

Study information

• Verified date: December 2020
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 22, 2019
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Out-patient clinic on demand (patient-initiated)
Free use of any resources in the out-patient clinic
• Scheduled out-patient clinic
Scheduled use of the out-patient clinic

Locations

Country	Name	City	State
Denmark	Hospital of South West Jutland, University hospital of Southern Denmark	Esbjerg

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcome	Questionnaire regarding satisfaction of the out-patient clinic	24 month
Secondary	Clinical diabetes variables 1	HbA1c	24 month
Secondary	Health Care Economy	Use of resources in the out-patient clinic	24 month
Secondary	Clinical diabetes variables 2	Blood pressure	24 month
Secondary	Clinical diabetes variables 3	Lipids	24 month
Secondary	Diabetes Dependent quality of Life	Questionnaire	24 month