Young With Diabetes Type 1 - Test of an mHealth App

NCT02632383 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glycemic control measured by HbA1c

  Glycemic control is measured by HbA1c at 12 months

Secondary Outcomes (3)

• Problem areas in diabetes measured by PAID-20

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

• Perceived competences in diabetes measured by PCD-questionnaire

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

• Health Care Climate measured by HCCQ-questionnaire

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

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group receives standard care

Interventions

Young with Diabetes - app DEVICE

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

Test Group

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 Diabetes
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Herlev Hospital: collaborator
• Steno Diabetes Center Copenhagen: collaborator
• Zealand University Hospital: collaborator

Study Sites (6)

Steno Diabetes Center

Gentofte Municipality, Gentofte, 2820, Denmark

Location

Pediatric and Adolescent Department, Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød

Hillerød, Hillerød, 3400, Denmark

Location

Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød

Hillerød, Hillerød, 3400, Denmark

Location

Department of Endocrinology, Køge Hospital

Køge, Køge, 4600, Denmark

Location

Pediatric Department, Roskilde Hospital

Roskilde, Roskilde, 4000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 29945861 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pernille Castensøe-Seidenfaden

  Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: March 28, 2017
• Study Completion: March 28, 2017
• Last Updated: April 10, 2017

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)