Young With Diabetes Type 1 - Test of an mHealth App

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Young With Diabetes Type 1 - Test of an mHealth App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632383
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: April 7, 2017
• Start date: December 2015
• Est. completion date: March 28, 2017

Study information

• Verified date: December 2015
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• 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

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte
Denmark	Pediatric and Adolescent Department, Herlev Hospital	Herlev
Denmark	Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød	Hillerød
Denmark	Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød	Hillerød
Denmark	Department of Endocrinology, Køge Hospital	Køge
Denmark	Pediatric Department, Roskilde Hospital	Roskilde

Sponsors (4)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Herlev Hospital, Steno Diabetes Center, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control measured by HbA1c		Glycemic control is measured by HbA1c at 12 months
Secondary	Problem areas in diabetes measured by PAID-20		Problem areas in diabetes are measured by PAID-20 at 12 months
Secondary	Perceived competences in diabetes measured by PCD-questionnaire		Perceived competences in diabetes are measured by PCD-questionnaire at 12 months
Secondary	Health Care Climate measured by HCCQ-questionnaire		Health Care Climate is measured by HCCQ-questionnaire at 12 months