Young With Diabetes Type 1 - Test of an mHealth App

• Sponsor: Nordsjaellands Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02632383
• Collaborator: Herlev Hospital (Other), Steno Diabetes Center Copenhagen (Other), Zealand University Hospital (Other)
• Enrollment: 140
• Locations: 6
• Arms: 2
• Duration (Months): 15.9
• Patients Per Site: 23.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Device: Young with Diabetes - app	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Young With Diabetes Type 1 - Test of an mHealth App
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Mar 28, 2017
• Actual Study Completion Date: Mar 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group 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; 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: Control Group The control group receives standard care

Outcome Measures

Primary Outcome Measures

1. Glycemic control measured by HbA1c [Glycemic control is measured by HbA1c at 12 months]

Secondary Outcome Measures

1. Problem areas in diabetes measured by PAID-20 [Problem areas in diabetes are measured by PAID-20 at 12 months]

2. Perceived competences in diabetes measured by PCD-questionnaire [Perceived competences in diabetes are measured by PCD-questionnaire at 12 months]

3. Health Care Climate measured by HCCQ-questionnaire [Health Care Climate is measured by HCCQ-questionnaire at 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 22 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Steno Diabetes Center	Gentofte		Denmark	2820
2	Pediatric and Adolescent Department, Herlev Hospital	Herlev		Denmark	2730
3	Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød	Hillerød		Denmark	3400
4	Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød	Hillerød		Denmark	3400
5	Department of Endocrinology, Køge Hospital	Køge		Denmark	4600
6	Pediatric Department, Roskilde Hospital	Roskilde		Denmark	4000

Sponsors and Collaborators

• Nordsjaellands Hospital
• Herlev Hospital
• Steno Diabetes Center Copenhagen
• Zealand University Hospital

Investigators

• Principal Investigator: Pernille Castensøe-Seidenfaden, Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nordsjaellands Hospital
• ClinicalTrials.gov Identifier: NCT02632383
• Other Study ID Numbers: 1
• First Posted: Dec 16, 2015
• Last Update Posted: Apr 10, 2017
• Last Verified: Dec 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Nordsjaellands Hospital: Diabetes type 1; Transition; Telemedicine; mHealth app; Youth; Self-management
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Apr 10, 2017