Young With Diabetes Type 1 - Test of an mHealth App
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02632383|
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Young with Diabetes - app||Not Applicable|
Young people with diabetes type 1, their parents and health care providers have participated in developing the mHealth app "Young with Diabetes".
The aim of the app is to support young people to self-manage their diabetes type 1.
A test group of 70 young people with diabetes type 1 test the app for 12 months as a supplement to standard care and the control group receives standard care only.
At baseline and after 2, 7 and 12 months HbA1c, problem areas in diabetes, perceived competences in diabetes and health care climate are measured.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Young With Diabetes Type 1 - Test of an mHealth App|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||March 28, 2017|
|Actual Study Completion Date :||March 28, 2017|
Experimental: Test Group
Intervention: Young with Diabetes - app The test group receives standard care and the mHealth app "Young with Diabetes" - app to support young people to self-manage their diabetes.
The young people's parents are also invited to download the app. The diabetes team (doctors, nurses and dieticians) also have the app and uses the app in their consultations with the young people.
Device: Young with Diabetes - app
The mHealth app "Young with Diabetes" containes 8 main functions:
No Intervention: Control Group
The control group receives standard care
- Glycemic control measured by HbA1c [ Time Frame: Glycemic control is measured by HbA1c at 12 months ]
- Problem areas in diabetes measured by PAID-20 [ Time Frame: Problem areas in diabetes are measured by PAID-20 at 12 months ]
- Perceived competences in diabetes measured by PCD-questionnaire [ Time Frame: Perceived competences in diabetes are measured by PCD-questionnaire at 12 months ]
- Health Care Climate measured by HCCQ-questionnaire [ Time Frame: Health Care Climate is measured by HCCQ-questionnaire at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632383
|Steno Diabetes Center|
|Gentofte, Denmark, 2820|
|Pediatric and Adolescent Department, Herlev Hospital|
|Herlev, Denmark, 2730|
|Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød|
|Hillerød, Denmark, 3400|
|Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød|
|Hillerød, Denmark, 3400|
|Department of Endocrinology, Køge Hospital|
|Køge, Denmark, 4600|
|Pediatric Department, Roskilde Hospital|
|Roskilde, Denmark, 4000|
|Principal Investigator:||Pernille Castensøe-Seidenfaden||Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød|