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Completed

NCT Number: NCT02632383

Young With Diabetes Type 1 - Test of an mHealth App

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center, Gentofte Municipality, Gentofte, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Young with Diabetes - app

Device

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

Primary outcomes

  1. Glycemic control measured by HbA1c

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

Secondary outcomes

  1. Problem areas in diabetes measured by PAID-20

    Time frame: Problem areas in diabetes are measured by PAID-20 at 12 months

  2. Perceived competences in diabetes measured by PCD-questionnaire

    Time frame: Perceived competences in diabetes are measured by PCD-questionnaire at 12 months

  3. Health Care Climate measured by HCCQ-questionnaire

    Time frame: Health Care Climate is measured by HCCQ-questionnaire at 12 months

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2015
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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