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Young With Diabetes Type 1 - Test of an mHealth App

Young With Diabetes Type 1 - Test of an mHealth App

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02632383
Enrollment
140
Registered
2015-12-16
Start date
2015-12-31
Completion date
2017-03-28
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes type 1, Transition, Telemedicine, mHealth app, Youth, Self-management

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.

Interventions

DEVICEYoung with Diabetes - app

The mHealth app Young with Diabetes containes 8 main functions: 1. Contact your health care provider (ask questions, set the agenda for the next clinical visit) 2. My Department (hotline numbers, videos about the new adult department, pictures of my diabetes team) 3. Chatroom 4. Counting Carbohydrates (information and tips about carbs, introduction to apps to count carbs, quiz) 5. Knowledge-section (Text, links, tips and videos (animations and videoselfies) about What is diabetes?, Alcohol etc.) 6. Tips packages (Receive a tip about alcohol, drivers license etc.) 7. 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) 8. Reminder

Sponsors

Herlev Hospital
CollaboratorOTHER
Steno Diabetes Center Copenhagen
CollaboratorOTHER
Zealand University Hospital
CollaboratorOTHER
Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 22 Years
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

Design outcomes

Primary

MeasureTime frame
Glycemic control measured by HbA1cGlycemic control is measured by HbA1c at 12 months

Secondary

MeasureTime frame
Problem areas in diabetes measured by PAID-20Problem areas in diabetes are measured by PAID-20 at 12 months
Perceived competences in diabetes measured by PCD-questionnairePerceived competences in diabetes are measured by PCD-questionnaire at 12 months
Health Care Climate measured by HCCQ-questionnaireHealth Care Climate is measured by HCCQ-questionnaire at 12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026