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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| Steno Diabetes Center Copenhagen | OTHER |
| Zealand University Hospital | OTHER |
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A multicenter randomized controlled trial testing the app "Young with Diabetes"
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | The control group receives standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Young with Diabetes - app | Device | The mHealth app "Young with Diabetes" containes 8 main functions:
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control measured by HbA1c | Glycemic control is measured by HbA1c at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Type 1 Diabetes
14 to 22 years old
followed at one of the six diabetes departments/centers
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille Castensøe-Seidenfaden | Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center | Gentofte Municipality | Gentofte | 2820 | Denmark | ||
| Pediatric and Adolescent Department, Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29945861 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Health Care Climate measured by HCCQ-questionnaire | Health Care Climate is measured by HCCQ-questionnaire at 12 months |
| Herlev |
| Herlev |
| 2730 |
| Denmark |
| Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød | Hillerød | Hillerød | 3400 | Denmark |
| Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød | Hillerød | Hillerød | 3400 | Denmark |
| Department of Endocrinology, Køge Hospital | Køge | Køge | 4600 | Denmark |
| Pediatric Department, Roskilde Hospital | Roskilde | Roskilde | 4000 | Denmark |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |