Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 2:51 AM
Study NCT ID:
NCT04612933
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2020-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
Sponsor:
University of Southern Denmark
Organization:
Study Overview
Official Title:
Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
Status:
COMPLETED
Status Verified Date:
2025-03
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:
Telemedicine is a solution to overcome distance and ensure the provision of healthcare services. This study aims to investigate the effects of conducting outpatient clinic visits remotely, for patients living with insulin pumps.
Detailed Description:
Telemedicine also has the potential to be a cost-effective solution due to reductions in travelling costs and saved working days, as well as increased patient satisfaction due to the reduction in transportation time.
Several studies have evaluated telemedicine for use in Diabetes Mellitus patients with an insulin pump. In all of these studies, the telemedicine group scheduled more contacts with the health care professionals than in the standard care group. To the investigator's knowledge, no one has investigated telemedicine, compared to standard care with the same number of scheduled contacts. The investigators believe telemedicine should increase the level of service and not increase the workload for health care professionals. A telemedical solution can provide patients with a more flexible alternative for visiting their health care provider rather having the burden of extra telemedicine appointments plus regular treatment.
Patients in rural Denmark may have a travelling time of 70 km (1 hour by car or several hours by public transport) to a specialised Diabetes Mellitus specialist centre. This may result in some patients choosing not to start or not being offered insulin pump treatment despite indications that an insulin pump is an optimal treatment choice. The challenge of distance also poses problems for patients in relation to technical problems or medical issues with the insulin pump. Telemedicine should be a solution for both patients and their Health Care Providers.
In this randomised controlled study, the effects of conducting clinical visits remotely, for patients living with insulin pumps will be investigated. Participants will be allocated to either Intervention (Standard care provide by video consultations) or standard care.
Several studies have evaluated telemedicine for use in Diabetes Mellitus patients with an insulin pump. In all of these studies, the telemedicine group scheduled more contacts with the health care professionals than in the standard care group. To the investigator's knowledge, no one has investigated telemedicine, compared to standard care with the same number of scheduled contacts. The investigators believe telemedicine should increase the level of service and not increase the workload for health care professionals. A telemedical solution can provide patients with a more flexible alternative for visiting their health care provider rather having the burden of extra telemedicine appointments plus regular treatment.
Patients in rural Denmark may have a travelling time of 70 km (1 hour by car or several hours by public transport) to a specialised Diabetes Mellitus specialist centre. This may result in some patients choosing not to start or not being offered insulin pump treatment despite indications that an insulin pump is an optimal treatment choice. The challenge of distance also poses problems for patients in relation to technical problems or medical issues with the insulin pump. Telemedicine should be a solution for both patients and their Health Care Providers.
In this randomised controlled study, the effects of conducting clinical visits remotely, for patients living with insulin pumps will be investigated. Participants will be allocated to either Intervention (Standard care provide by video consultations) or standard care.
Study Oversight
Has Oversight DMC:
False
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?: