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The Diabetes Patient Takes Responsibility (DiaTast)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Out-patient clinic on demand (patient-initiated)
Scheduled out-patient clinic
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes, Organization, Out-patient control

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of South West Jutland, University hospital of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diatast

Control

Arm Description

Free patient-initiated use of out-patient services

Scheduled diabetes control

Outcomes

Primary Outcome Measures

Patient reported outcome
Questionnaire regarding satisfaction of the out-patient clinic

Secondary Outcome Measures

Clinical diabetes variables 1
HbA1c
Health Care Economy
Use of resources in the out-patient clinic
Clinical diabetes variables 2
Blood pressure
Clinical diabetes variables 3
Lipids
Diabetes Dependent quality of Life
Questionnaire

Full Information

First Posted
March 3, 2017
Last Updated
December 11, 2020
Sponsor
Hospital of South West Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT03083899
Brief Title
The Diabetes Patient Takes Responsibility
Acronym
DiaTast
Official Title
DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 22, 2019 (Actual)
Study Completion Date
December 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital of South West Jutland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Patient Reported Outcome, Health Care Economics and Organizations
Keywords
Diabetes, Organization, Out-patient control

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diatast
Arm Type
Experimental
Arm Description
Free patient-initiated use of out-patient services
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Scheduled diabetes control
Intervention Type
Other
Intervention Name(s)
Out-patient clinic on demand (patient-initiated)
Intervention Description
Free use of any resources in the out-patient clinic
Intervention Type
Other
Intervention Name(s)
Scheduled out-patient clinic
Intervention Description
Scheduled use of the out-patient clinic
Primary Outcome Measure Information:
Title
Patient reported outcome
Description
Questionnaire regarding satisfaction of the out-patient clinic
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Clinical diabetes variables 1
Description
HbA1c
Time Frame
24 month
Title
Health Care Economy
Description
Use of resources in the out-patient clinic
Time Frame
24 month
Title
Clinical diabetes variables 2
Description
Blood pressure
Time Frame
24 month
Title
Clinical diabetes variables 3
Description
Lipids
Time Frame
24 month
Title
Diabetes Dependent quality of Life
Description
Questionnaire
Time Frame
24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus B Juhl, MD PhD
Organizational Affiliation
Hospital of South West Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of South West Jutland, University hospital of Southern Denmark
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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The Diabetes Patient Takes Responsibility

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