NCT03083899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

March 3, 2017

Last Update Submit

December 11, 2020

Conditions

Diabetes Mellitus, Type 1Patient Reported OutcomeHealth Care Economics and Organizations

Keywords

DiabetesOrganizationOut-patient control

Outcome Measures

Primary Outcomes (1)

  • Patient reported outcome

    Questionnaire regarding satisfaction of the out-patient clinic

    24 month

Secondary Outcomes (5)

  • Clinical diabetes variables 1

    24 month

  • Health Care Economy

    24 month

  • Clinical diabetes variables 2

    24 month

  • Clinical diabetes variables 3

    24 month

  • Diabetes Dependent quality of Life

    24 month

Study Arms (2)

Diatast

EXPERIMENTAL

Free patient-initiated use of out-patient services

Other: Out-patient clinic on demand (patient-initiated)

Control

PLACEBO COMPARATOR

Scheduled diabetes control

Other: Scheduled out-patient clinic

Interventions

Out-patient clinic on demand (patient-initiated)OTHER

Free use of any resources in the out-patient clinic

Diatast
Scheduled out-patient clinicOTHER

Scheduled use of the out-patient clinic

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy

You may not qualify if:

  • Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of South West Jutland, University hospital of Southern Denmark

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Claus B Juhl, MD PhD

    Esbjerg Hospital - University Hospital of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Ass Professor

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 20, 2017

Study Start

March 1, 2017

Primary Completion

December 22, 2019

Study Completion

December 22, 2019

Last Updated

December 14, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)