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Young With Diabetes Type 1 - Test of an mHealth App

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Young with Diabetes - app
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes type 1, Transition, Telemedicine, mHealth app, Youth, Self-management

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steno Diabetes Center
  • Pediatric and Adolescent Department, Herlev Hospital
  • Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
  • Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
  • Department of Endocrinology, Køge Hospital
  • Pediatric Department, Roskilde Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test Group

Control Group

Arm Description

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.

The control group receives standard care

Outcomes

Primary Outcome Measures

Glycemic control measured by HbA1c

Secondary Outcome Measures

Problem areas in diabetes measured by PAID-20
Perceived competences in diabetes measured by PCD-questionnaire
Health Care Climate measured by HCCQ-questionnaire

Full Information

First Posted
December 2, 2015
Last Updated
April 7, 2017
Sponsor
Nordsjaellands Hospital
Collaborators
Herlev Hospital, Steno Diabetes Center Copenhagen, Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02632383
Brief Title
Young With Diabetes Type 1 - Test of an mHealth App
Official Title
Young With Diabetes Type 1 - Test of an mHealth App
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
March 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital
Collaborators
Herlev Hospital, Steno Diabetes Center Copenhagen, Zealand University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes type 1, Transition, Telemedicine, mHealth app, Youth, Self-management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group receives standard care
Intervention Type
Device
Intervention Name(s)
Young with Diabetes - app
Intervention Description
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 Outcome Measure Information:
Title
Glycemic control measured by HbA1c
Time Frame
Glycemic control is measured by HbA1c at 12 months
Secondary Outcome Measure Information:
Title
Problem areas in diabetes measured by PAID-20
Time Frame
Problem areas in diabetes are measured by PAID-20 at 12 months
Title
Perceived competences in diabetes measured by PCD-questionnaire
Time Frame
Perceived competences in diabetes are measured by PCD-questionnaire at 12 months
Title
Health Care Climate measured by HCCQ-questionnaire
Time Frame
Health Care Climate is measured by HCCQ-questionnaire at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille Castensøe-Seidenfaden
Organizational Affiliation
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Pediatric and Adolescent Department, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Department of Endocrinology, Køge Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Pediatric Department, Roskilde Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29945861
Citation
Castensoe-Seidenfaden P, Husted GR, Jensen AK, Hommel E, Olsen B, Pedersen-Bjergaard U, Kensing F, Teilmann G. Testing a Smartphone App (Young with Diabetes) to Improve Self-Management of Diabetes Over 12 Months: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 26;6(6):e141. doi: 10.2196/mhealth.9487.
Results Reference
derived

Learn more about this trial

Young With Diabetes Type 1 - Test of an mHealth App

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