Young With Diabetes Type 1 - Test of an mHealth App

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Young with Diabetes - app

• Registration Number: NCT02632383
• Lead Sponsor: Nordsjaellands Hospital

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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Primary Completion: 2017-03-28
• Study Completion: 2017-03-28
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Young with Diabetes - app	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.

Primary Outcome Measures

Name	Time	Method
Glycemic control measured by HbA1c	Glycemic control is measured by HbA1c at 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark

Pediatric and Adolescent Department, Herlev Hospital; 🇩🇰 Herlev, Denmark

Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød; 🇩🇰 Hillerød, Denmark

Department of Endocrinology, Køge Hospital; 🇩🇰 Køge, Denmark

Pediatric Department, Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød; 🇩🇰 Hillerød, Denmark