Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04233138 |
| Other study ID # |
SUPPORT |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 5, 2020 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
April 2022 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There are evidences that some healthcare teams are not proposing new therapeutic and
technology options that have the potential to reduce hypoglycemia for people with type 1
diabetes. In practice, people living with type 1 diabetes report receiving education related
to insulin pumps usage mainly on key functions (how the device works) at initiation and not
enough about proactive adjustments (how to optimally use the device) especially on the
long-term. In brief, short-term education is technical and product-specific, rather than
being based on patients' needs.There is a need to test the efficacy of different programs
that may be more suited to patients' needs and desires while offering the opportunity to
reduce costs (e.g. web based). Since there is a lack of expertise related to optimal use of
new technologies and therapies for people living with type 1 diabetes, we propose to design
and test a web-based training (e.g. courses including videos and quizzes) and support (e.g.
discussion forum) platform. This will be tested through a registry-based trial.
The overall purpose of this study is to evaluate, among a group of adults living with type 1
diabetes, the SUPPORT online education platform in terms of users' satisfaction, engagement
and efficacy to change the fear and the frequency of hypoglycemia.
Description:
Design and development of the SUPPORT platform:
The SUPPORT platform was designed based on the Behavior change wheel framework. The research
team identified the main barriers in achieving adequate blood glucose management and in the
use of an online training platform; then, features (downloadable PDFs, videos, quizzes, etc.)
were designed to overcome these barriers. These training modules were developed by a team
including two dietitians/certified diabetes educator, a nurse, a psychologist and
endocrinologist (all specialized in type 1 diabetes). The content was then reviewed by the
committee of patient-partners and clinicians working in type 1 diabetes (one endocrinologist,
two residents in endocrinology, two dietitians (1 being a certified diabetes educator) and
two nurses (1 being a certified diabetes educator).
Recruitment and intervention:
Recruitment of people with type 1 diabetes will be done via an email sent to the participants
who completed phase 2 of the BETTER registry, are 18 years old or older, and agreed to be
contacted for other studies. All participants accepting to participate will receive the full
intervention for 6 months (access to the platform with bi-weekly newsletters). During the
following 6 months, participants will still have access to the platform, but no newsletter
will be sent (sustainability phase). Questionnaires will be given at baseline, 6-month, and
12-month of the intervention to assess fear of hypoglycemia, diabetes knowledge, overall
satisfaction of the platform. Participant will also receive 1 question every 6 weeks
regarding the frequency of hypoglycemia during the last 3 days. The observational control
group will not have access to the platform. We will extract data from the baseline, 6 months
and annual registry completion.
Analysis:
Initial analysis will be descriptive and baseline data will be summarized separately for both
groups. Baseline continuous data will be reported as means with standard deviations (median
and interquartile range if data are skewed). Categorical data will be reported as
proportions. Our primary outcome is the difference in mean self-reported hypoglycemia and
fear of hypoglycemia score between the 2 groups after 6 months of intervention. The primary
outcome will be calculated and compared between the two groups using differences with 95% CI
using paired t-test and McNemar test. Analysis will be by intention to treat.
Sample size and pairing:
Every participant in the intervention group will be randomly paired by gender and date of
completion of the phase 2 BETTER questionnaire (+/- 1 month) with a participant who answered
the second phase of the BETTER registry but who did not respond to the invitation e-mail for
the SUPPORT study. We have calculated the number of pairs to be able to detect a 25%
reduction in adults given the small but present difference in self-reported hypoglycemia in
both age groups. We estimate a 25% reduction in hypoglycemic episodes for a between-group
difference of 0.95. Assuming a common standard deviation of 4.5, for a 2-sided alpha=0.05 and
80% power to detect such a difference with sample size calculation for comparing paired
differences, we will require 179 pairs of participants in total. Allowing for a up to 35%
loss to follow-up, we will require 275 pairs of participants.
Importance of this study:
Once validated, the SUPPORT online training platform for individuals with type 1 diabetes can
be a low-cost and easily accessible training to complement regular care and increase
knowledge of diabetes-related therapies and technologies.
