Clinical trial NCT02632383: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes type 1
Transition
Telemedicine
mHealth app
Youth
Self-management
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Steno Diabetes Center Copenhagen
name: Zealand University Hospital
First posted: 2015-12-16
Enrollment: 140
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Glycemic control measured by HbA1c
timeFrame: Glycemic control is measured by HbA1c at 12 months
Secondary outcomes:
measure: Problem areas in diabetes measured by PAID-20
timeFrame: Problem areas in diabetes are measured by PAID-20 at 12 months
measure: Perceived competences in diabetes measured by PCD-questionnaire
timeFrame: Perceived competences in diabetes are measured by PCD-questionnaire at 12 months
measure: Health Care Climate measured by HCCQ-questionnaire
timeFrame: Health Care Climate is measured by HCCQ-questionnaire at 12 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
city: Herlev
country: Denmark
facility: Pediatric and Adolescent Department, Herlev Hospital
city: Hillerød
country: Denmark
facility: Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
city: Hillerød
country: Denmark
facility: Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
city: Køge
country: Denmark
facility: Department of Endocrinology, Køge Hospital
city: Roskilde
country: Denmark
facility: Pediatric Department, Roskilde Hospital
Study officials:
affiliation: Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
name: Pernille Castensøe-Seidenfaden
role: PRINCIPAL_INVESTIGATOR
References:
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.