Young With Diabetes Type 1 - Test of an mHealth App

Nordsjaellands Hospital

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Young with Diabetes - app

Study type: Interventional

Funder types: Other

Identifiers

NCT02632383

1

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 14 to 22 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Test Group

Experimental group

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.

Treatment:

Device: Young with Diabetes - app

Control Group

No Intervention group

Description:

The control group receives standard care