The Diabetes Patient Takes Responsibility

Not Applicable

Completed

• Conditions: Patient Reported Outcome; Health Care Economics and Organizations; Diabetes Mellitus, Type 1
• Interventions: Other: Scheduled out-patient clinic; Other: Out-patient clinic on demand (patient-initiated)

• Registration Number: NCT03083899
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Primary Completion: 2019-12-22
• Study Completion: 2019-12-22
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Scheduled out-patient clinic	Scheduled diabetes control
Diatast	Out-patient clinic on demand (patient-initiated)	Free patient-initiated use of out-patient services

Primary Outcome Measures

Name	Time	Method
Patient reported outcome	24 month	Questionnaire regarding satisfaction of the out-patient clinic

Secondary Outcome Measures

Name	Time	Method
Clinical diabetes variables 1	24 month	HbA1c
Health Care Economy	24 month	Use of resources in the out-patient clinic
Clinical diabetes variables 2	24 month	Blood pressure
Clinical diabetes variables 3	24 month	Lipids
Diabetes Dependent quality of Life	24 month	Questionnaire

Trial Locations

Locations (1)

Hospital of South West Jutland, University hospital of Southern Denmark; 🇩🇰 Esbjerg, Denmark