Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-16
SponsorAnne-Sophie Brazeau

About this trial

The investigators will conduct a randomized controlled trial (RCT) to examine how an online training and peer support platform could help the preparation to transition to adult care. Among 14-16 year old youth with Type 1 Diabetes (T1D), the investigators aim to assess the effect of an online training and peer support platform (Support-t) integrated in usual care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures during the preparation for transition to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority RCT of adolescents with T1D (14-16 years of age) followed at one of 4 university teaching hospital-based pediatric diabetes clinics in the province of Quebec.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents with a clinical diagnosis of T1D

14-16 years of age

Receiving diabetes care at one of 4 university teaching hospital-based pediatric diabetes clinics in Quebec: Montreal Children's Hospital-McGill University Health Centre, Centre hospitalier universitaire de Sherbrooke, Le Copain-Hôpital de Gatineau, Centre Hospitalier Universitaire de Québec

Having access to internet

Disqualifiers

Severe neurocognitive disabilities

Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c

Trial design

Design model

Parallel

Treatments tested in this trial

  • Support-t

    Other intervention

    Support-t plus usual diabetes care for 18 months

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Support-t plus usual diabetes careExperimental treatment 1 intervention
Group B: Usual diabetes care onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline Hemaglobin A1c (HbA1c) at 18 months

HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test

Time frame
18 months

Secondary outcomes

1

Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months

HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test

Time frame
6, 12 months
2

Continuous Glucose Monitoring (CGM) - % Time in range

% Time in range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart

Time frame
0, 6, 12, 18 months
3

Continuous Glucose Monitoring (CGM) - % Time above range

% Time above range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart

Time frame
0, 6, 12, 18 months
4

Continuous Glucose Monitoring (CGM) - % Time below range

% Time below range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart

Time frame
0, 6, 12, 18 months

Other outcomes

1

Engagement with Support-t platform (T1D patient) - time in minutes on platform

Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform

Time frame
6, 12, 18 months
2

Engagement with Support-t platform (T1D patient) - discussion forum participation

Engagement metrics will be extracted using Google analytics - participation on the platform discussion forum

Time frame
6, 12, 18 months
3

Engagement with Support-t platform (T1D patient) - content accessed

Engagement metrics will be extracted using Google analytics - specific content accessed from the platform

Time frame
6, 12, 18 months
4

Engagement with Support-t platform (T1D patient) - total pages viewed

Engagement metrics will be extracted using Google analytics - total pages viewed from the platform

Time frame
6, 12, 18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anne-Sophie Brazeau

Lead sponsor

McGill University

Sponsor institution

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

CSSS de Gatineau

Collaborator

Centre de recherche du CHU de Sherbrooke

Collaborator

CHU de Quebec-Universite Laval

Collaborator