Short summary

The aim of the study is to test a new model of organizing the diabetes outpatient clinic for Type 1 diabetes patients. The new model aims at a higher degree of self-planning in the patients´ use of the outpatient clinic based on patients' needs. Patients are randomized to follow the normal scheduled visit procedure in the outpatient clinic or to have open access to the clinic within guaranteed time intervals.

Primary outcome is patient reported outcome (PRO) measures of patient satisfaction.

Secondary outcomes are clinical diabetes status (clinical variables), health economic evaluations of resources used in the outpatient clinic and by patients, and PRO measures of patient characteristics/personal preferences.

A secure internet website ("Diabetes-online") will be used by all patients to follow their own diabetic test results. In addition the website is used by the intervention group to communicate about booking of visits to the clinic.   

Rationale

The organization of the life-long control of Type 1 diabetes by pre-planned visits is challenged in this study. The aim is to give capable patients the opportunity to have a higher degree of influence on their disease management and furthermore to allocate clinical resources to those patients that require a more structured and assisted disease management.

Description of the cohort

• Type 1 diabetes patients (users of multi insulin injection or insulin pump)
• Diabetes for a minimum of 6 months
• Age 18-80 years
• Patients of the outpatient clinic at Hospital South West Jutland
• Internet and cell phone users 

Exclusion criteria:

• Patients with severe psychiatric illness, dementia, or other conditions that may compromise the patient´s judgement of the need of attendance to the clinic or otherwise pose a safety risk
• Unstable late-onset diabetic complications (progressive retinopathy or current foot ulcers)
• Major increase in HbA1c (>30 mmole/mole within 3 months or >40 mmole/mole in 6 months)
• Need for interpreter
• Pregnancy
• Participation in another intervention project within the last month

Data and biological material

Questionnaires/PRO

• Q1: Self-designed validated questionnaire about patient satisfaction, patient expenses, and self-perception.
• Q2: Audit of Diabetes Dependent Quality of Life questionnaire (ADDQoL)

Clinical data: 

• Blood and urine sample analyzes, diabetes related clinical data, and diabetes variables submitted to the Danish Clinical Registries (RKKP) of Diabetes.

Register data:

• Data on in-hospital admissions for ketoacidosis and hypoglycemia (The National Patient Register/Landspatientregistret)
• Data on visits at the general practitioner (The National Health Service Register/Sygesikringsregistret) 

Collaborating researchers and departments

Center for Health Economics Research - COHERE, University of Southern Denmark

• Professor & Director of COHERE Dorte Gyrd-Hansen
• Associate professor Trine Kjær

Knowledge Center for User Involvement (ViBIS)

• Jesper Leck