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The Diabetes Patient Takes Responsibility (DiaTast)

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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

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE March 20, 2017
Last Update Posted Date December 14, 2020
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date December 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
Patient reported outcome [ Time Frame: 24 month ]
Questionnaire regarding satisfaction of the out-patient clinic
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Clinical diabetes variables 1 [ Time Frame: 24 month ]
    HbA1c
  • Health Care Economy [ Time Frame: 24 month ]
    Use of resources in the out-patient clinic
  • Clinical diabetes variables 2 [ Time Frame: 24 month ]
    Blood pressure
  • Clinical diabetes variables 3 [ Time Frame: 24 month ]
    Lipids
  • Diabetes Dependent quality of Life [ Time Frame: 24 month ]
    Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Diabetes Patient Takes Responsibility
Official Title  ICMJE DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Patient Reported Outcome
  • Health Care Economics and Organizations
Intervention  ICMJE
  • Other: Out-patient clinic on demand (patient-initiated)
    Free use of any resources in the out-patient clinic
  • Other: Scheduled out-patient clinic
    Scheduled use of the out-patient clinic
Study Arms  ICMJE
  • Experimental: Diatast
    Free patient-initiated use of out-patient services
    Intervention: Other: Out-patient clinic on demand (patient-initiated)
  • Placebo Comparator: Control
    Scheduled diabetes control
    Intervention: Other: Scheduled out-patient clinic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2020)
357
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2017)
500
Actual Study Completion Date  ICMJE December 22, 2019
Actual Primary Completion Date December 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03083899
Other Study ID Numbers  ICMJE Diatast
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Claus Bogh Juhl, Hospital of South West Jutland
Study Sponsor  ICMJE Hospital of South West Jutland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claus B Juhl, MD PhD Hospital of South West Jutland
PRS Account Hospital of South West Jutland
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP