Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Diabetes Patient Takes Responsibility (DiaTast)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083899
Recruitment Status : Completed
First Posted : March 20, 2017
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Claus Bogh Juhl, Hospital of South West Jutland

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Patient Reported Outcome Health Care Economics and Organizations Other: Out-patient clinic on demand (patient-initiated) Other: Scheduled out-patient clinic Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : December 22, 2019
Actual Study Completion Date : December 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diatast
Free patient-initiated use of out-patient services
Other: Out-patient clinic on demand (patient-initiated)
Free use of any resources in the out-patient clinic

Placebo Comparator: Control
Scheduled diabetes control
Other: Scheduled out-patient clinic
Scheduled use of the out-patient clinic




Primary Outcome Measures :
  1. Patient reported outcome [ Time Frame: 24 month ]
    Questionnaire regarding satisfaction of the out-patient clinic


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083899


Locations
Layout table for location information
Denmark
Hospital of South West Jutland, University hospital of Southern Denmark
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Jutland
Investigators
Layout table for investigator information
Principal Investigator: Claus B Juhl, MD PhD Hospital of South West Jutland
Layout table for additonal information
Responsible Party: Claus Bogh Juhl, MD, PhD, Ass Professor, Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT03083899    
Other Study ID Numbers: Diatast
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claus Bogh Juhl, Hospital of South West Jutland:
Diabetes
Organization
Out-patient control
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases