Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT03202732
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2017-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
Sponsor:
Annesofie Lunde Jensen
Organization:
Study Overview
Official Title:
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.
The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.
The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.
Detailed Description:
Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.
The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.
The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.
The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.
The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: