Young With Diabetes Type 1 - Test of an mHealth App

Nordsjaellands Hospital6 sites in 1 country140 target enrollmentDecember 2015

ConditionsDiabetes Mellitus, Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Nordsjaellands Hospital
Enrollment: 140
Locations: 6
Primary Endpoint: Glycemic control measured by HbA1c
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

March 28, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nordsjaellands Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Glycemic control measured by HbA1c

Time Frame: Glycemic control is measured by HbA1c at 12 months

Secondary Outcomes

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)