Type 1 DiabetesNCT02107326
Randomized Crossover Study to Test the Impact of Using a Software for Smartphones and Tablets in Treating Type 1 Diabetes
A study testing Webdia Software in people with Type 1 Diabetes and Quality of Life, run by Philippe Klee at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Quality of Life, Hypoglycaemia
- What is being tested?
- Webdia Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to 1 Oct 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10 - 18 years
- Type 1 diabetes mellitus with positive auto-antibodies against Islet Antigen (IA) 2, insulin, islets, Glutamic Acid Decarboxylase (GAD) 65 or Zink
- Disease duration equal or more than 6 months
- Treatment by subcutaneous insulin: by multiple daily injections of pump therapy
Who cannot join
- Previous use of Webdia Software
- Absence of hardware necessary to install the Webdia Software
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Webdia Study: Use of Smartphones to Improve Diabetes Control and Quality of Life in Children With Type 1 Diabetes
The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life
Read the detailed description
The hypothesis underlying this project, is that most calculations necessary for flexible intensive insulin therapy for type 1 diabetes in children can be performed using software installed on a smartphone or tablet that nowadays is carried by most parents and children. Smartphones and tablets can easily communicate with each other and with a desktop computer via the Internet, thereby permitting the exchange of information such as blood glucose values or types of meals among family members and physicians. Finally, software collecting blood glucose values and merging values obtained on different devices easily permits reviewing these values by the patient and sending them to the physician's office, thereby avoiding consultations during which no blood glucose values are brought by the patient.
We hypothesize that the Webdia software, that will be tested in this randomized crossover study, will increase treatment compliance and therefore will improve diabetes self-management. We believe, the software will facilitate the adaptation of insulin schemes by physicians and therefore will lead to improved HbA1C values. We also think that this software will improve the patient's quality of life.
- Conditions
- Type 1 Diabetes, Quality of Life, Hypoglycaemia
- Being tested
- Webdia Software
- Keywords
- Type 1 diabetes, HbA1C, Quality of Life, Hypoglycaemia, Self-management, Telemedicine
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Webdia SoftwareDevice
| Study group | Role | What they receive |
|---|---|---|
| Webdia Software use | Experimental | Use of Webdia Software during 3 months by the patient. Monthly review of blood glucose values by the medical team and automatic adjustment of insulin doses by the team. Receives: Device: Webdia Software |
| Observation | No intervention | No use of the software. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Webdia Software use on HbA1C
Measured: 0, 3, 6 and 9 months after inclusion
Secondary outcomes (2)
Effect of Webdia Software use on quality of life
Quality of life assessment by the use of the Diabetes Quality of Life for Youths (DQOLY) questionnaire published by Ingersoll et al. 1991.
Measured: 0, 3, 6 and 9 months after inclusion
Effect of Webdia Software use on the incidence of hypoglycaemic events
Measured: During 2 weeks at the end of the 3-months period of Webdia Software use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion15 Aug 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippe Klee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe Klee, University Hospital, Geneva
- Investigators
- Philippe Klee, MD-PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107326
- Sponsor's protocol ID
- CER13-272
- Status last verified
- Oct 2017
- First submitted
- 3 Apr 2014
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Webdia Study: Use of Smartphones to Improve Diabetes Control and Quality of Life in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02107326
- Acronym / sponsor ID
- CER13-272
- Conditions
- Type 1 Diabetes, Quality of Life, Hypoglycaemia
- Keywords
- Type 1 diabetes, HbA1C, Quality of Life, Hypoglycaemia, Self-management, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Philippe KleeUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 8 Apr 2014 (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.
The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life
Detailed description
The hypothesis underlying this project, is that most calculations necessary for flexible intensive insulin therapy for type 1 diabetes in children can be performed using software installed on a smartphone or tablet that nowadays is carried by most parents and children. Smartphones and tablets can easily communicate with each other and with a desktop computer via the Internet, thereby permitting the exchange of information such as blood glucose values or types of meals among family members and physicians. Finally, software collecting blood glucose values and merging values obtained on different devices easily permits reviewing these values by the patient and sending them to the physician's office, thereby avoiding consultations during which no blood glucose values are brought by the patient.
We hypothesize that the Webdia software, that will be tested in this randomized crossover study, will increase treatment compliance and therefore will improve diabetes self-management. We believe, the software will facilitate the adaptation of insulin schemes by physicians and therefore will lead to improved HbA1C values. We also think that this software will improve the patient's quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Webdia Software use | Experimental | Device: Webdia SoftwareUse of Webdia Software during 3 months by the patient. Monthly review of blood glucose values by the medical team and automatic adjustment of insulin doses by the team. |
| Observation | No intervention | –No use of the software. No intervention. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 10 - 18 years
- Type 1 diabetes mellitus with positive auto-antibodies against Islet Antigen (IA) 2, insulin, islets, Glutamic Acid Decarboxylase (GAD) 65 or Zink
- Disease duration equal or more than 6 months
- Treatment by subcutaneous insulin: by multiple daily injections of pump therapy
Key exclusion criteria (2 listed)
- Previous use of Webdia Software
- Absence of hardware necessary to install the Webdia Software
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 |
|---|---|---|
| Webdia Software | Device | Webdia Software use |
Primary outcome
Effect of Webdia Software use on HbA1C
Time frame: 0, 3, 6 and 9 months after inclusion
2 secondary outcomes
Effect of Webdia Software use on quality of life
Time frame: 0, 3, 6 and 9 months after inclusion
Effect of Webdia Software use on the incidence of hypoglycaemic events
Time frame: During 2 weeks at the end of the 3-months period of Webdia Software use
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 19 Oct 2017.
- Homepage of the Webdia Software being tested in this studyLink provided by the sponsor.
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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.
Philippe Klee, MD-PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Webdia Software in people with Type 1 Diabetes and Quality of Life, run by Philippe Klee at 1 site in Switzerland.
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 4 inclusion and 2 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Effect of Webdia Software use on HbA1C (time frame: 0, 3, 6 and 9 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2017.