Young With Diabetes Type 1 - Test of an mHealth App

April 7, 2017 updated by: Nordsjaellands Hospital
A multicenter randomized controlled trial testing the app "Young with Diabetes"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes Center
      • Herlev, Denmark, 2730
        • Pediatric and Adolescent Department, Herlev Hospital
      • Hillerød, Denmark, 3400
        • Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
      • Hillerød, Denmark, 3400
        • Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
      • Køge, Denmark, 4600
        • Department of Endocrinology, Køge Hospital
      • Roskilde, Denmark, 4000
        • Pediatric Department, Roskilde Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic control measured by HbA1c
Time Frame: Glycemic control is measured by HbA1c at 12 months
Glycemic control is measured by HbA1c at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Problem areas in diabetes measured by PAID-20
Time Frame: Problem areas in diabetes are measured by PAID-20 at 12 months
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
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
Health Care Climate is measured by HCCQ-questionnaire at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Collaborators

Zealand University Hospital
Herlev Hospital
Steno Diabetes Center Copenhagen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 28, 2017

Study Completion (Actual)

March 28, 2017

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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