Clinical trial NCT02462785: An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes
Official title: Carbohydrate Counting and Type 1 Diabetes: A Randomized Controlled Trial of Internet-based Teaching for Adolescents Learning to Count
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Adolescents
Carbohydrate Counting
Glycemic Control
Self-Management
T1DM
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2015-06-04
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education
timeFrame: Baseline; 3-months post-education
Secondary outcomes:
measure: Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education
timeFrame: Baseline; 3-months post-education
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jill Hamilton, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: