Young With Diabetes Type 1 - Test of an mHealth App

Study Overview
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Brief Summary
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A multicenter randomized controlled trial testing the app Young with Diabetes

Detailed Description
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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.

Official Title
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Young With Diabetes Type 1 - Test of an mHealth App

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Young with Diabetes - app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 Diabetes 14 to 22 years old followed at one of the six diabetes departments/centers Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød Pediatric and Adolescent Department, Herlev Hospital Steno Diabetes Center, Gentofte Pediatric Department, Roskilde Hospital 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: A psychical or psychiatric disorder that enables them to use the app Participates in other diabetes interventions Sees a psychologist or psychiatrist Have participated in developing the app Young with Diabetes

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>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<br>* The mHealth app Young with Diabetes containes 8 main functions: Contact your health care provider (ask questions, set the agenda for the next clinical visit) My Department (hotline numbers, videos about the new adult department, pictures of my diabetes team) Chatroom Counting Carbohydrates (information and tips about carbs, introduction to apps to count carbs, quiz) Knowledge-section (Text, links, tips and videos (animations and videoselfies) about What is diabetes?, Alcohol etc.) Tips packages (Receive a tip about alcohol, drivers license etc.) 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) Reminder<br>|
| No Intervention: Control Group<br>The control group receives standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control measured by HbA1c |  | Glycemic control is measured by HbA1c at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problem areas in diabetes measured by PAID-20 |  | Problem areas in diabetes are measured by PAID-20 at 12 months | 
| Perceived competences in diabetes measured by PCD-questionnaire |  | Perceived competences in diabetes are measured by PCD-questionnaire at 12 months | 
| Health Care Climate measured by HCCQ-questionnaire |  | Health Care Climate is measured by HCCQ-questionnaire at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes type 1, Transition, Telemedicine, mHealth app, Youth, Self-management