Type 1 Diabetes MellitusNCT02462785
An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes
A study testing In-person Carbohydrate Counting Class and Online Carbohydrate Counting Tutorial in people with Type 1 Diabetes Mellitus, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Helping individuals with diabetes to control their blood sugars through self-management is an important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and management. There is very little research examining CHO counting education with adolescents who have type 1 diabetes (T1DM). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- In-person Carbohydrate Counting Class and Online Carbohydrate Counting Tutorial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Sep 2016
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents aged 12-17 years with a diagnosis of T1DM for more than 1 year
- Followed at the SickKids Diabetes Clinic
- Have access to a computer with Internet connection
- Able to communicate in English
Who cannot join
- Patients with type 2 diabetes, medication-induced diabetes or other forms of non T1DM
- Patients with Celiac disease, due to differences in prescribed dietary regimen
- Patients who are unable to communicate in English
- No computer or internet access
- Patient with cognitive delay impeding their ability to learn CHO counting
- Patients who have attended a CHO counting class within the past 6 months
- Patients who do not eat the foods presented on the planned meal \& snack trays
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
About this study
Official title: Carbohydrate Counting and Type 1 Diabetes: A Randomized Controlled Trial of Internet-based Teaching for Adolescents Learning to Count
Helping individuals with diabetes to control their blood sugars through self-management is an important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and management. There is very little research examining CHO counting education with adolescents who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years, with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO counting tutorial could be used to strengthen current diabetes education programs and may serve as a basis for developing other teaching modules. Advantages of web-based teaching include convenience, increased accessibility, and the ability to review and reinforce teaching concepts through repetition. It may also encourage adolescents to take the initiative for their own diabetes care, beginning with a self-directed, active learning experience.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- In-person Carbohydrate Counting Class, Online Carbohydrate Counting Tutorial
- Keywords
- Type 1 Diabetes Mellitus, Adolescents, Carbohydrate Counting, Glycemic Control, Self-Management, T1DM
- 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.
In-person Carbohydrate Counting ClassBehavioural
An in-person carbohydrate counting class led by a registered dietician. The in class session covers topics including the role of CHO in nutrition and diabetes, sources of CHO, different CHO and non-CHO foods, resources for CHO counting, label reading, and meal planning. This is the standard procedure for CHO counting education at SickKids.
Online Carbohydrate Counting TutorialBehavioural
A web-based CHO counting tutorial that covers the same concepts reviewed during the standard in-person instructional session held at SickKids. A teen delivers the educational messages in short segments using techniques designed to maintain the viewer's attention (e.g., visuals of food portions and short segment highlights to emphasize important points). The online module includes brief interactive question/answer components for reinforcement. The secure online tutorial will be accessible for one week through a link provided by REDCap. Users will be able to repeat sessions, log on and off during sessions, and choose specific modules for repetition/review. The investigators will be able to capture the number of times patients log on and detail frequency and specifics of usage.
| Study group | Role | What they receive |
|---|---|---|
| In-Class Instruction | Active comparator | This group of adolescents will receive carbohydrate counting instruction through an in-person, in class session led by a registered dietician. This represents the usual standard of care at the Diabetes Clinic at The Hospital for Sick Children (SickKids). Receives: Behavioral: In-person Carbohydrate Counting Class |
| Internet-Based Teaching | Experimental | This group of adolescents will receive carbohydrate counting instruction through an online teaching tutorial. Receives: Behavioral: Online Carbohydrate Counting Tutorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education
Test trays will comprise foods commonly consumed by adolescents (e.g., hamburger, grilled cheese sandwich). CHO counting accuracy using food trays will be checked against a computerized food analysis. Several tray combinations will be used with randomization to tray order within each group for both pre- and post- assessments.
Measured: Baseline; 3-months post-education
Secondary outcomes (1)
Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education
A 52 item assessment of carbohydrate and insulin dose calculating knowledge in youth with T1DM
Measured: Baseline; 3-months post-education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Lawson Foundation
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill Hamilton, MD, M.Sc., Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462785
- Sponsor's protocol ID
- 1000042623
- Status last verified
- Nov 2017
- First submitted
- 12 May 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Counting and Type 1 Diabetes: A Randomized Controlled Trial of Internet-based Teaching for Adolescents Learning to Count
- ClinicalTrials.gov ID
- NCT02462785
- Acronym / sponsor ID
- 1000042623
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Adolescents, Carbohydrate Counting, Glycemic Control, Self-Management, T1DM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Lawson Foundation
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Jun 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.
Helping individuals with diabetes to control their blood sugars through self-management is an important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and management. There is very little research examining CHO counting education with adolescents who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years, with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO counting tutorial could be used to strengthen current diabetes education programs and may serve as a basis for developing other teaching modules. Advantages of web-based teaching include convenience, increased accessibility, and the ability to review and reinforce teaching concepts through repetition. It may also encourage adolescents to take the initiative for their own diabetes care, beginning with a self-directed, active learning experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Class Instruction | Active comparator | Behavioral: In-person Carbohydrate Counting ClassThis group of adolescents will receive carbohydrate counting instruction through an in-person, in class session led by a registered dietician. This represents the usual standard of care at the Diabetes Clinic at The Hospital for Sick Children (SickKids). |
| Internet-Based Teaching | Experimental | Behavioral: Online Carbohydrate Counting TutorialThis group of adolescents will receive carbohydrate counting instruction through an online teaching tutorial. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents aged 12-17 years with a diagnosis of T1DM for more than 1 year
- Followed at the SickKids Diabetes Clinic
- Have access to a computer with Internet connection
- Able to communicate in English
Key exclusion criteria (7 listed)
- Patients with type 2 diabetes, medication-induced diabetes or other forms of non T1DM
- Patients with Celiac disease, due to differences in prescribed dietary regimen
- Patients who are unable to communicate in English
- No computer or internet access
- Patient with cognitive delay impeding their ability to learn CHO counting
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 |
|---|---|---|
| In-person Carbohydrate Counting ClassAn in-person carbohydrate counting class led by a registered dietician. The in class session covers topics including the role of CHO in nutrition and diabetes, sources of CHO, different CHO and non-CHO foods, resources for CHO counting, label reading, and meal planning. This is the standard procedure for CHO counting education at SickKids. | Behavioural | In-Class Instruction |
| Online Carbohydrate Counting TutorialA web-based CHO counting tutorial that covers the same concepts reviewed during the standard in-person instructional session held at SickKids. A teen delivers the educational messages in short segments using techniques designed to maintain the viewer's attention (e.g., visuals of food portions and short segment highlights to emphasize important points). The online module includes brief interactive question/answer components for reinforcement. The secure online tutorial will be accessible for one week through a link provided by REDCap. Users will be able to repeat sessions, log on and off during sessions, and choose specific modules for repetition/review. The investigators will be able to capture the number of times patients log on and detail frequency and specifics of usage. | Behavioural | Internet-Based Teaching |
Primary outcome
Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education
Time frame: Baseline; 3-months post-education
Test trays will comprise foods commonly consumed by adolescents (e.g., hamburger, grilled cheese sandwich). CHO counting accuracy using food trays will be checked against a computerized food analysis. Several tray combinations will be used with randomization to tray order within each group for both pre- and post- assessments.
1 secondary outcome
Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education
Time frame: Baseline; 3-months post-education
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 17 Nov 2017.
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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.
Jill Hamilton, MD, M.Sc. principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person Carbohydrate Counting Class and Online Carbohydrate Counting Tutorial in people with Type 1 Diabetes Mellitus, run by The Hospital for Sick Children at 1 site in Canada.
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 7 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 17 Nov 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 Canada. 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?
Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education (time frame: Baseline; 3-months post-education). 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 17 Nov 2017.