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Young With Diabetes Type 1 - Test of an mHealth App

This study has been completed.
Sponsor:
Collaborators:
Herlev Hospital
Steno Diabetes Center
Zealand University Hospital
Information provided by (Responsible Party):
Nordsjaellands Hospital
ClinicalTrials.gov Identifier:
NCT02632383
First received: December 2, 2015
Last updated: April 7, 2017
Last verified: December 2015
  Purpose
A multicenter randomized controlled trial testing the app "Young with Diabetes"

Condition Intervention
Diabetes Mellitus, Type 1 Device: Young with Diabetes - app

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Young With Diabetes Type 1 - Test of an mHealth App

Resource links provided by NLM:


Further study details as provided by Nordsjaellands Hospital:

Primary Outcome Measures:
  • Glycemic control measured by HbA1c [ Time Frame: Glycemic control is measured by HbA1c at 12 months ]

Secondary Outcome Measures:
  • Problem areas in diabetes measured by PAID-20 [ Time Frame: Problem areas in diabetes are measured by PAID-20 at 12 months ]
  • Perceived competences in diabetes measured by PCD-questionnaire [ Time Frame: Perceived competences in diabetes are measured by PCD-questionnaire at 12 months ]
  • Health Care Climate measured by HCCQ-questionnaire [ Time Frame: Health Care Climate is measured by HCCQ-questionnaire at 12 months ]

Estimated Enrollment: 140
Study Start Date: December 2015
Study Completion Date: March 28, 2017
Primary Completion Date: March 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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
No Intervention: Control Group
The control group receives standard care

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.

  Eligibility

Ages Eligible for Study:   14 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02632383

Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Pediatric and Adolescent Department, Herlev Hospital
Herlev, Denmark, 2730
Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
Hillerød, Denmark, 3400
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
Hillerød, Denmark, 3400
Department of Endocrinology, Køge Hospital
Køge, Denmark, 4600
Pediatric Department, Roskilde Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nordsjaellands Hospital
Herlev Hospital
Steno Diabetes Center
Zealand University Hospital
Investigators
Principal Investigator: Pernille Castensøe-Seidenfaden Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
  More Information

Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT02632383     History of Changes
Other Study ID Numbers: 1
Study First Received: December 2, 2015
Last Updated: April 7, 2017
Individual Participant Data  
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 26, 2017