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Diabetes MellitusNCT01249742

Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

A study testing Internet intervention in people with Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background The treatment of diabetes is multidisciplinary. Alignment of care of the various professional disciplines is, however, not always optimal. This can lead to confusion about treatment interventions and behavioral advices. Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Internet intervention
How many people
65 participants
Where
1 siteNetherlands
Study dates
Feb 2009to Nov 2010
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 12 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • adolescents aged 12 and older;
  • diagnosed with diabetes mellitus;
  • receiving regular outpatient hospital-delivered diabetes care provided by the Children's Diabetes Center Nijmegen (CDCN)

Who cannot join

  • adolescents who were unable to read questionnaires because of language, or cognitive problems were excluded

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Children's Diabetes Center Nijmegen

    Nijmegen, Gelderland, Postbus 9015; 6500 GS

Other trials in Netherlands

About this study

Background

The treatment of diabetes is multidisciplinary. Alignment of care of the various professional disciplines is, however, not always optimal. This can lead to confusion about treatment interventions and behavioral advices. In adolescence, good fine-tuned care is of extreme importance because of the difficulties in regulation of the disease in this phase of life (Snoek, 2004). These difficulties are due to biological changes but also to socio-psychological developmental changes. The adolescents' psychological development demands more autonomy and responsibility for the diabetes (care) by the adolescent. The social development can conflict with the treatment regime, because of the adolescents' social needs (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess whether an interactive website, on which adolescents with diabetes and their treatment team can communicate, leads to better alignment of care and better control over the disease.

Read more

Intervention

The diabetes has great impact on the adolescents' everyday life. Finding a balance between more autonomy, participating in social life with (healthy) peers and control of the disease is difficult and seems to act as a thread during this phase in life.

This can lead to questions and uncertainty at any given moment. The interactive website provides the adolescent access to information and to his or her individual treatment plan and advices fitted to his or her condition and life. The adolescent can pose questions at any given moment through the online forum and their personal treatment page. Since the treatment team answers the question within a day, fit between diabetes care and adolescents' everyday life is optimized.

Research question

Does an online interactive treatment environment, on which adolescents with diabetes can communicate with their treatment team, lead to better fit of care and to better disease control?

Being tested
Internet intervention
Keywords
diabetes mellitus, adolescent, online intervention, psychosocial, quality of life
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet interventionBehavioural

    Our intervention, Sugarsquare, is a secured treatment environment only accessible by patients of the KDCN and members of the treatment team. Sugarsquare consists of two main sections. The first section is a semi-public setting on which adolescents can exchange experiences with their diabetes (care) through a forum and a real time chat-application. All patients and treatment team members can see all messages posted here. The second section consists of patients' individual pages with treatment overview and an application for private interaction with the treatment team. Patients can only access their own individual page; treatment team members can access pages of all patients. Sugarsquare is a secured webpage, accessible only through computers equipped with the right certificate (access device) and by using the appointed username-password combination.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients' Evaluation of Quality of Care

    Participants' appreciation of our diabetes care was assessed using the Patients' Evaluation of Quality of Diabetes care (PEQ-D; Pouwer \& Snoek, 2002). This questionnaire consists of 14 items, such as: 'The amount of information I receive from the doctor is…'. The adolescent is asked to answer by means of a 5-point lykert scale varying from 1) bad to 5) excellent.

    Measured: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

Secondary outcomes (5)

  1. Health Related Quality of Life

    Health-related quality of life was measured by means of the PedsQl 3.0 diabetes module (Varni, 2004). The Dutch translation was used, which shows good psychometric properties for clinical application in pediatric diabetes care (de Wit, 2008). The questionnaire consists of 28 items and can be subdivided into five subscales; diabetes symptoms, treatment barriers, treatment adherence, worry, and communication. Example of item: 'I feel hungry' (subscale diabetes symptoms). Al items can be answered using a 5-point lykert scale, varying from 0 (never) to 4 (almost always).

    Measured: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  2. Adolescents' disease knowledge

    Diabetes knowledge was measured using the Diabetes Knowledge Questionnaire (Fitzgerald, 1998). This questionnaire has shown to have good psychometric properties (Fitzgerald, 1998). The questionnaire was translated in Dutch especially for this study. The final Dutch version, DKT-NL, consisted of 21 multiple choice questions, such as 'sings of ketoacidosis include… '. Possible answers were: a) shakiness, b) sweating, c) vomiting (right answer), d) low blood glucose .

    Measured: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  3. Confidence In Diabetes Selfcare

    Participants' self-efficacy was determined through use of the Confidence In Diabetes Selfcare questionnaire (CIDS; van de ven, 2004). The questionnaire contains 20 items, all referring to the perceived ability to perform diabetes self-care tasks. All items are preceded by "I believe I can… ," and can be answered on a 5-point lykert scale, varying from 1) "No, I am sure I cannot" to 5) "Yes, I am sure I can"). An example is "I believe I can… adjust my insulin when I am sick".

    Measured: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  4. Glycemic control (HbA1c)

    Patients' Glycemic control was derived from their files. 'Old' HbA1c values were converted to new HbA1c values using the calculator of the Dutch Diabetes Federation (NDF, 2010). New HbA1c values were used in the analyses.

    Measured: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  5. Degree of use of intervention

    The degree of use of our intervention was measured by frequency of use of adolescents of different applications. We therefore logged all action of adolescents on Sugarsquare. Examples of variables are number of page views, number of posted messages on the forum, number of attended chat sessions and number of started discussions with professional caregivers. Table 3 gives insight in all actions included in the analysis.

    Measured: T1 (6 months following start of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2010 (estimated)
  2. Study startFeb 2009
  3. Primary completionApr 2010
  4. Study completionNov 2010

Resources

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
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01249742
Sponsor's protocol ID
2007.13.003
Status last verified
Nov 2010
First submitted
22 Nov 2010
Last updated
30 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • Boogerd EA, Noordam C, Kremer JA, Prins JB, Verhaak CM. Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Aug;15(5):394-402. doi: 10.1111/pedi.12103. Epub 2013 Dec 18.

    PubMed 24350732

Questions about this trial

What is this clinical trial studying?

A study testing Internet intervention in people with Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.

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 3 inclusion and 1 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 30 Nov 2010. 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 Netherlands. 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?

Patients' Evaluation of Quality of Care (time frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).). 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 NCT01249742, 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 30 Nov 2010.

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