Diabetes Mellitus, Type 1NCT02632383
Young With Diabetes Type 1 - Test of an mHealth App
A study testing Young with Diabetes - app in people with Diabetes Mellitus, Type 1, run by Nordsjaellands Hospital at 6 sites in Denmark.
Trial summary
A multicenter randomized controlled trial testing the app "Young with Diabetes" Read more about this study
- Who is it for?
- Ages 14 to 22 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Young with Diabetes - app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesDenmark
- Study dates
- Dec 2015to 28 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Steno Diabetes Center
Gentofte Municipality, Gentofte, 2820
Pediatric and Adolescent Department, Herlev Hospital
Herlev, Herlev, 2730
Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
Hillerød, Hillerød, 3400
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
Hillerød, Hillerød, 3400
Department of Endocrinology, Køge Hospital
Køge, Køge, 4600
Pediatric Department, Roskilde Hospital
Roskilde, Roskilde, 4000
About this study
A multicenter randomized controlled trial testing the app "Young with Diabetes"
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Young with Diabetes - app
- Keywords
- Diabetes type 1, Transition, Telemedicine, mHealth app, Youth, Self-management
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young with Diabetes - appDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Young with Diabetes - app |
| Control Group | No intervention | The control group receives standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control measured by HbA1c
Measured: Glycemic control is measured by HbA1c at 12 months
Secondary outcomes (3)
Problem areas in diabetes measured by PAID-20
Measured: Problem areas in diabetes are measured by PAID-20 at 12 months
Perceived competences in diabetes measured by PCD-questionnaire
Measured: Perceived competences in diabetes are measured by PCD-questionnaire at 12 months
Health Care Climate measured by HCCQ-questionnaire
Measured: Health Care Climate is measured by HCCQ-questionnaire at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Steno Diabetes Center Copenhagen, Zealand University Hospital
- Responsible party
- Sponsor
- Investigators
- Pernille Castensøe-Seidenfaden, Principal investigator, Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632383
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29945861
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young With Diabetes Type 1 - Test of an mHealth App
- ClinicalTrials.gov ID
- NCT02632383
- Acronym / sponsor ID
- 1
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes type 1, Transition, Telemedicine, mHealth app, Youth, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital, Steno Diabetes Center Copenhagen, Zealand University Hospital
- Study start
- Dec 2015
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Young with Diabetes - appIntervention: 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 |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Young with Diabetes - appThe 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 | Device | Test Group |
Primary outcome
Glycemic control measured by HbA1c
Time frame: Glycemic control is measured by HbA1c at 12 months
3 secondary outcomes
Problem areas in diabetes measured by PAID-20
Time frame: Problem areas in diabetes are measured by PAID-20 at 12 months
Perceived competences in diabetes measured by PCD-questionnaire
Time frame: Perceived competences in diabetes are measured by PCD-questionnaire at 12 months
Health Care Climate measured by HCCQ-questionnaire
Time frame: Health Care Climate is measured by HCCQ-questionnaire at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Derived from this study: PubMed 29945861Castensoe-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Castensøe-Seidenfaden principal investigator
Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young with Diabetes - app in people with Diabetes Mellitus, Type 1, run by Nordsjaellands Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control measured by HbA1c (time frame: Glycemic control is measured by HbA1c at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.