Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2015-12-31
2017-03-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Young with Diabetes - app
The mHealth app "Young with Diabetes" containes 8 main functions:
1. Contact your health care provider (ask questions, set the agenda for the next clinical visit)
2. My Department (hotline numbers, videos about the new adult department, pictures of my diabetes team)
3. Chatroom
4. Counting Carbohydrates (information and tips about carbs, introduction to apps to count carbs, quiz)
5. Knowledge-section (Text, links, tips and videos (animations and videoselfies) about What is diabetes?, Alcohol etc.)
6. Tips packages (Receive a tip about alcohol, drivers license etc.)
7. To parents (Text, links, tips and videoselfies to parents about what it is like to be young with diabetes and what they can do to support)
8. Reminder
Control Group
The control group receives standard care
No interventions assigned to this group
Interventions
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Young with Diabetes - app
The mHealth app "Young with Diabetes" containes 8 main functions:
1. Contact your health care provider (ask questions, set the agenda for the next clinical visit)
2. My Department (hotline numbers, videos about the new adult department, pictures of my diabetes team)
3. Chatroom
4. Counting Carbohydrates (information and tips about carbs, introduction to apps to count carbs, quiz)
5. Knowledge-section (Text, links, tips and videos (animations and videoselfies) about What is diabetes?, Alcohol etc.)
6. Tips packages (Receive a tip about alcohol, drivers license etc.)
7. To parents (Text, links, tips and videoselfies to parents about what it is like to be young with diabetes and what they can do to support)
8. Reminder
Eligibility Criteria
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Inclusion Criteria
* 14 to 22 years old
* followed at one of the six diabetes departments/centers
1. Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
2. Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
3. Pediatric and Adolescent Department, Herlev Hospital
4. Steno Diabetes Center, Gentofte
5. Pediatric Department, Roskilde Hospital
6. Department of Endocrinology, Køge Hospital
* have an iOS or android smartphone
* last measured HbA1c before sending out recruiting letters: 64 mmol/mol or more (if the last measured HbA1c is older than 6 months at time of baseline visit a new HbA1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized)
* mean of the three last measured HbA1c before sending out recruiting letters: 58 mmol/mol or more (if the third last HbA1c is older than 18 months at time of baseline visit a new HbA1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized)
Exclusion Criteria
* Participates in other diabetes interventions
* Sees a psychologist or psychiatrist
* Have participated in developing the app Young with Diabetes
14 Years
22 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Steno Diabetes Center Copenhagen
OTHER
Zealand University Hospital
OTHER
Nordsjaellands Hospital
OTHER
Responsible Party
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Principal Investigators
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Pernille Castensøe-Seidenfaden
Role: PRINCIPAL_INVESTIGATOR
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
Locations
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Steno Diabetes Center
Gentofte Municipality, Gentofte, Denmark
Pediatric and Adolescent Department, Herlev Hospital
Herlev, Herlev, Denmark
Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
Hillerød, Hillerød, Denmark
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
Hillerød, Hillerød, Denmark
Department of Endocrinology, Køge Hospital
Køge, Køge, Denmark
Pediatric Department, Roskilde Hospital
Roskilde, Roskilde, Denmark
Countries
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References
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Castensoe-Seidenfaden P, Husted GR, Jensen AK, Hommel E, Olsen B, Pedersen-Bjergaard U, Kensing F, Teilmann G. Testing a Smartphone App (Young with Diabetes) to Improve Self-Management of Diabetes Over 12 Months: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 26;6(6):e141. doi: 10.2196/mhealth.9487.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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