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The Diabetes Patient Takes Responsibility

NCT ID: NCT03083899

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-12-22

Brief Summary

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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

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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.

Conditions

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

Keywords

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Diabetes Organization Out-patient control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Diatast

Free patient-initiated use of out-patient services

Group Type EXPERIMENTAL

Out-patient clinic on demand (patient-initiated)

Intervention Type OTHER

Free use of any resources in the out-patient clinic

Control

Scheduled diabetes control

Group Type PLACEBO_COMPARATOR

Scheduled out-patient clinic

Intervention Type OTHER

Scheduled use of the out-patient clinic

Interventions

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Out-patient clinic on demand (patient-initiated)

Free use of any resources in the out-patient clinic

Intervention Type OTHER

Scheduled out-patient clinic

Scheduled use of the out-patient clinic

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Claus Bogh Juhl

MD, PhD, Ass Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claus B Juhl, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Esbjerg Hospital - University Hospital of Southern Denmark

Locations

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Hospital of South West Jutland, University hospital of Southern Denmark

Esbjerg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Diatast

Identifier Type: -

Identifier Source: org_study_id