Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment young with diabetes - app
Sponsor Nordsjaellands Hospital
Collaborator Herlev Hospital
Start date December 2015
End date April 2017
Trial size 140 participants
Trial identifier NCT02632383, 1

Summary

A multicenter randomized controlled trial testing the app "Young with Diabetes"

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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: 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
(No Intervention)
The control group receives standard care

Primary Outcomes

Measure
Glycemic control measured by HbA1c
time frame: Glycemic control is measured by HbA1c at 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 14 years up to 22 years old.

Inclusion Criteria: - Type 1 Diabetes - 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: - 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

Additional Information

Official title Young With Diabetes Type 1 - Test of an mHealth App
Principal investigator Pernille Castensøe-Seidenfaden
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Nordsjaellands Hospital.