Diabetes Mellitus, Type 1GET-IT-T1DNCT03703440
Group Education Trial to Improve Transition in Type 1 Diabetes
A study testing Active arm in people with Diabetes Mellitus, Type 1 and Type1diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
The investigators will conduct a randomized controlled trial (RCT) to examine group education visits as an innovative and potentially cost-effective approach to transition care delivery, that can be easily integrated into usual diabetes care. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type1diabetes, Insulin Dependent Diabetes
- What is being tested?
- Active arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Nov 2019to 17 Jul 2024
- 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 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents with a diagnosis of Type 1 Diabetes
- 16 to 17 years of age
- Receiving diabetes care at one of two university teaching hospital-based pediatric diabetes clinics in Montreal: Montreal Children's Hospital (MCH) or Centre Hospitalier Universitaire Sainte Justine (CHUSJ)
- Fluent in English or French
Who cannot join
- Severe neurocognitive disabilities that may preclude patient's ability to participate in a group education visit
- Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre Hospitalier Universitaire Sainte-Justine (CHUSJ)
Montreal, Quebec, H3T 1C5
Montreal Children's Hospital - McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
About this study
Official title: Evaluation of a Group Education Program to Improve the Transition From Pediatric to Adult Care for Emerging Adults With Type 1 Diabetes
The investigators will conduct a randomized controlled trial (RCT) to examine group education visits as an innovative and potentially cost-effective approach to transition care delivery, that can be easily integrated into usual diabetes care. Among emerging adults with type 1 diabetes (T1D), the investigators aim to assess the effect of group education visits integrated into pediatric care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures after the transfer to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment.
Read the detailed description
Rationale. The transition from pediatric to adult diabetes care is a challenging period for adolescents and emerging adults (ages 18-30 years) with type 1 diabetes (T1D). It is characterized by a deterioration in glycemic control (Hemoglobin A1c [HbA1c]), decreased adherence to self-management tasks and to clinic attendance and an increased risk of adverse outcomes. The investigators propose to examine group education visits as a potentially cost-effective approach. In emerging adults with T1D, the investigators hypothesize that group education visits, as compared with usual care, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes after the transfer to adult care.
Primary Aim. To determine the impact of group educations visits, compared with usual care, on HbA1c after the transfer to adult care.
Secondary Aims. 1. To determine the impact of group education visits, compared with usual care, on time between last pediatric and first adult T1D visit (gap > 6 months), emergency department (ED) visits and hospitalizations, severe hypoglycemic events, stigma, self-efficacy, disease knowledge, transition readiness, quality of life (QOL) and diabetes distress, after the transfer to adult care. 2. To determine the cost-effectiveness of group education visits.
Methods. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Patients will be recruited over 24 months. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio . Visits in the active arm will consist of a group education session followed by an individual appointment with the diabetes care physician every 3-months. The group education session, facilitated by a diabetes nurse educator or dietitian, will consist of a patient-driven discussion on topics relevant to adolescents with T1D. Patients in the control group, will have in parallel with the intervention group, individual appointments with their diabetes provider as per usual care. The primary outcome is the change in HbA1c measured at 24 months (HbA1c measured at 24 months - HbA1c measured at baseline). Secondary outcomes are delays in establishing adult T1D care (Y/N), T1D-related hospitalizations and ED-visits (rates/P-Y), severe hypoglycemic events, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, and QOL. Assessments are at baseline, 12 and 24 months . Analysis will be by intention to treat. Outcomes will be calculated and compared between the two trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis.
- Being tested
- Active arm, Control arm
- Keywords
- Transition care, Pediatric, Adolescent, Education, Hemaglobin A1c, Health Services, Randomized Controlled Trial
- 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.
Active armOther
≥3 group education sessions in addition to usual diabetes care, every 3 months for 12 months
Control armOther
Usual diabetes care, every 3-month for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | ≥3 group education sessions (60 minutes per session) in addition to usual diabetes care, every 3 months for 12 months. Each group session (3-8 patients per group) will be facilitated by a diabetes nurse educator and/or dietitian. The group session content will be guided by the needs of the group participants. The group discussion will end with participants setting goals for their next appointment. Receives: Other: Active arm |
| Control | Other | Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual diabetes care, an individual education session and written information will be provided before formal transfer. Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemaglobin A1c (HbA1c)
HbA1c will be measured using an A1c Test Kit, which is a non-fasting, finger stick, whole blood test
Measured: 0, 12, 24 months
Secondary outcomes (15)
Delay in establishing adult Diabetes Care (gap in care>6 months)
Delay greater than 6 months (Y/N) between the last Diabetes Care visit with a pediatric care physician and the first Diabetes Care visit with an adult care physician will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
Measured: 24 months
Delay in establishing adult Diabetes Care (days)
Time in days between the last Diabetes Care visit with a pediatric care physician and the first Diabetes Care visit with an adult care physician will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
Measured: 24 months
Diabetes-related hospitalizations
Any diabetes-related hospitalizations in the past 12 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from the Hospital Discharge Database (Med-Echo) and medical record chart
Measured: 0, 12, 24 months
Diabetes-related emergency department visits
Any diabetes-related emergency-department visits in the past 12 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
Measured: 0, 12, 24 months
Severe hypoglycemic events
Any patient-reported severe hypoglycemic events in the past 12 months
Measured: 0,12, 24 months
Stigma
Presence of stigma defined as an affirmative response to at least one of 3 key items on the Barriers to Diabetes Adherence in Adolescence (BDA) questionnaire stigma subscale (score >2 on a 5-point Likert-type scale)
Measured: 0,12, 24 months
Self-efficacy
Self-efficacy for Diabetes Self-Management Measure (SEDM) assesses self-efficacy. The score ranges from 1 to 10. All item scores are averaged to compute the score. A higher score represents a better outcome.
Measured: 0,12, 24 months
Diabetes knowledge
L'Aide aux Jeunes Diabétiques Diabetes Knowledge and Skills Questionnaire assesses diabetes knowledge. The score ranges from 0 to 50. The number of correct items are summed to compute the score. A higher score represents a better outcome.
Measured: 0, 12, 24 months
Transition readiness
Am I ON TRAC? For Adult Care Questionnaire (Youth Version of Questionnaire) measures transition readiness. Scores range from 13 to 64 on the Knowledge Scale. Item scores are summed to compute the Knowledge Scale score. Higher scores on the Knowledge Scale represent a better outcome. Raw scores range from 8 to 45 on the Behaviour Index. Item scores are summed to compute the raw scores on the Behaviour Index. Higher raw scores on the Behaviour Index represent a better outcome. Cut-off scores range from 0 to 9 on the Behaviour Index. Threshold scores are summed to compute the cut-off scores on the Behaviour Index. Higher cut-off scores on the Behaviour Index represent a better outcome.
Measured: 0, 12 months
Diabetes distress
Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) measures diabetes-related distress. The Total Score ranges from 1 to 6. All item scores are averaged to compute the Total Score. A higher Total Score represents a worse outcome. Scores range from 1 to 6 on the 7 Subscales (1. Powerlessness, 2. Management Distress, 3. Hypoglycemia Distress, 4. Negative Social Perceptions, 5. Eating Distress, 6. Physician Distress, 7. Friend/Family Distress) and Screener. Item scores are averaged to compute the Subscale and Screener scores. Higher Subscale and Screener scores represent a worse outcome.
Measured: 0, 12, 24 months
Quality of life (Generic Core)
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale assesses Health-Related Quality of Life. Scores are transformed on a scale from 0 to 100. The Scale Scores (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) range from 0 to 100. To create Scale Scores, the mean is computed as the sum of the items over the number of items answered. Higher Scale Scores represent a better outcome. To create the Psychosocial Health Summary Score, the mean is computed as the sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales. The Physical Health Summary Score is the same as the Physical Functioning Scale Score. The Total Scale Score ranges from 0 to 100. To create the Total Scale Score, the mean is computed as the sum of all the items over the number of items answered on all the Scales. A higher Total Scale Score represents a better outcome.
Measured: 0, 12, 24 months
Quality of life (Diabetes Module)
Pediatric Quality of Life Inventory (PedsQL) Diabetes Module assesses diabetes-specific quality of life. Scores are transformed on a scale from 0 to 100. The Scale Scores by Dimension (About My Diabetes, Treatment-I, Treatment II, Worry, and Communication) range from 0 to 100. To calculate Scale Scores by Dimension, the mean is computed as the sum of the items over the number of items answered. Higher Scale Scores represent a better outcome. To calculate the Total Score, the mean is computed as the sum of all the items over the number of items answered on all the Scales. A higher Total Score represents a better outcome.
Measured: 0, 12, 24 months
Cost effectiveness (HbA1c)
Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for HbA1c
Measured: 12 and 24 months
Cost effectiveness (QOL)
Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for QOL
Measured: 12 and 24 months
Cost effectiveness (self-efficacy)
Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for self-efficacy
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start19 Nov 2019
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Model description
- Active arm: Patients randomized to the active arm will be asked to attend ≥ 3 group education sessions, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits. Control arm: Patients randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- St. Justine's Hospital, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Meranda Nakhla, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Meranda Nakhla, MD, MSc, Principal investigator, Montreal Children's Hospital - McGill University Health Centre (MUHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703440
- Sponsor's protocol ID
- MP-37-2019-4434
- Acronym
- GET-IT-T1D
- Status last verified
- Nov 2024
- First submitted
- 9 Oct 2018
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data supporting the results reported in the published research articles, after de-identification will be available.
Publications
Brazeau AS, Nakhla M, Wright M, Henderson M, Panagiotopoulos C, Pacaud D, Kearns P, Rahme E, Da Costa D, Dasgupta K. Stigma and Its Association With Glycemic Control and Hypoglycemia in Adolescents and Young Adults With Type 1 Diabetes: Cross-Sectional Study. J Med Internet Res. 2018 Apr 20;20(4):e151. doi: 10.2196/jmir.9432.
PubMed 29678801Diabetes Canada Clinical Practice Guidelines Expert Committee; Wherrett DK, Ho J, Huot C, Legault L, Nakhla M, Rosolowsky E. Type 1 Diabetes in Children and Adolescents. Can J Diabetes. 2018 Apr;42 Suppl 1:S234-S246. doi: 10.1016/j.jcjd.2017.10.036. No abstract available.
PubMed 29650103Nakhla M, Rahme E, Simard M, Larocque I, Legault L, Li P. Risk of ketoacidosis in children at the time of diabetes mellitus diagnosis by primary caregiver status: a population-based retrospective cohort study. CMAJ. 2018 Apr 9;190(14):E416-E421. doi: 10.1503/cmaj.170676.
PubMed 29632036Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2.
PubMed 29577410Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.
PubMed 28761657Nakhla M, Rahme E, Simard M, Guttmann A. Outcomes associated with a pediatric clinical diabetes network in Ontario: a population-based time-trend analysis. CMAJ Open. 2017 Jul 24;5(3):E586-E593. doi: 10.9778/cmajo.20170022.
PubMed 28747349Brazeau AS, Nakhla M, Wright M, Panagiotopoulos C, Pacaud D, Henderson M, Rahme E, Da Costa D, Dasgupta K. Stigma and Its Impact on Glucose Control Among Youth With Diabetes: Protocol for a Canada-Wide Study. JMIR Res Protoc. 2016 Dec 15;5(4):e242. doi: 10.2196/resprot.6629.
PubMed 27979791Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.
PubMed 26498219Jefferies CA, Nakhla M, Derraik JG, Gunn AJ, Daneman D, Cutfield WS. Preventing Diabetic Ketoacidosis. Pediatr Clin North Am. 2015 Aug;62(4):857-71. doi: 10.1016/j.pcl.2015.04.002. Epub 2015 May 30.
PubMed 26210621Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.
PubMed 19933731Guttmann A, Nakhla M, Henderson M, To T, Daneman D, Cauch-Dudek K, Wang X, Lam K, Hux J. Validation of a health administrative data algorithm for assessing the epidemiology of diabetes in Canadian children. Pediatr Diabetes. 2010 Mar;11(2):122-8. doi: 10.1111/j.1399-5448.2009.00539.x. Epub 2009 Jun 5.
PubMed 19500278Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.
PubMed 18717235Mok E, Henderson M, Dasgupta K, Rahme E, Hajizadeh M, Bell L, Prevost M, Frei J, Nakhla M. Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D). BMJ Open. 2019 Nov 11;9(11):e033806. doi: 10.1136/bmjopen-2019-033806.
PubMed 31719096
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Group Education Program to Improve the Transition From Pediatric to Adult Care for Emerging Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03703440
- Acronym / sponsor ID
- GET-IT-T1D / MP-37-2019-4434
- Keywords
- Transition care, Pediatric, Adolescent, Education, Hemaglobin A1c, Health Services, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- St. Justine's Hospital, Canadian Institutes of Health Research (CIHR)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 12 Oct 2018 (actual)
- 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.
The investigators will conduct a randomized controlled trial (RCT) to examine group education visits as an innovative and potentially cost-effective approach to transition care delivery, that can be easily integrated into usual diabetes care. Among emerging adults with type 1 diabetes (T1D), the investigators aim to assess the effect of group education visits integrated into pediatric care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures after the transfer to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment.
Detailed description
Rationale. The transition from pediatric to adult diabetes care is a challenging period for adolescents and emerging adults (ages 18-30 years) with type 1 diabetes (T1D). It is characterized by a deterioration in glycemic control (Hemoglobin A1c [HbA1c]), decreased adherence to self-management tasks and to clinic attendance and an increased risk of adverse outcomes. The investigators propose to examine group education visits as a potentially cost-effective approach. In emerging adults with T1D, the investigators hypothesize that group education visits, as compared with usual care, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes after the transfer to adult care.
Primary Aim. To determine the impact of group educations visits, compared with usual care, on HbA1c after the transfer to adult care.
Secondary Aims. 1. To determine the impact of group education visits, compared with usual care, on time between last pediatric and first adult T1D visit (gap > 6 months), emergency department (ED) visits and hospitalizations, severe hypoglycemic events, stigma, self-efficacy, disease knowledge, transition readiness, quality of life (QOL) and diabetes distress, after the transfer to adult care. 2. To determine the cost-effectiveness of group education visits.
Methods. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Patients will be recruited over 24 months. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio . Visits in the active arm will consist of a group education session followed by an individual appointment with the diabetes care physician every 3-months. The group education session, facilitated by a diabetes nurse educator or dietitian, will consist of a patient-driven discussion on topics relevant to adolescents with T1D. Patients in the control group, will have in parallel with the intervention group, individual appointments with their diabetes provider as per usual care. The primary outcome is the change in HbA1c measured at 24 months (HbA1c measured at 24 months - HbA1c measured at baseline). Secondary outcomes are delays in establishing adult T1D care (Y/N), T1D-related hospitalizations and ED-visits (rates/P-Y), severe hypoglycemic events, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, and QOL. Assessments are at baseline, 12 and 24 months . Analysis will be by intention to treat. Outcomes will be calculated and compared between the two trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Active arm: Patients randomized to the active arm will be asked to attend ≥ 3 group education sessions, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits. Control arm: Patients randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Active arm≥3 group education sessions (60 minutes per session) in addition to usual diabetes care, every 3 months for 12 months. Each group session (3-8 patients per group) will be facilitated by a diabetes nurse educator and/or dietitian. The group session content will be guided by the needs of the group participants. The group discussion will end with participants setting goals for their next appointment. |
| Control | Other | Other: Control armUsual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual diabetes care, an individual education session and written information will be provided before formal transfer. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents with a diagnosis of Type 1 Diabetes
- 16 to 17 years of age
- Receiving diabetes care at one of two university teaching hospital-based pediatric diabetes clinics in Montreal: Montreal Children's Hospital (MCH) or Centre Hospitalier Universitaire Sainte Justine (CHUSJ)
- Fluent in English or French
Key exclusion criteria (2 listed)
- Severe neurocognitive disabilities that may preclude patient's ability to participate in a group education visit
- Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c
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 |
|---|---|---|
| Active arm≥3 group education sessions in addition to usual diabetes care, every 3 months for 12 months | Other | Active |
| Control armUsual diabetes care, every 3-month for 12 months | Other | Control |
Primary outcome
Hemaglobin A1c (HbA1c)
Time frame: 0, 12, 24 months
HbA1c will be measured using an A1c Test Kit, which is a non-fasting, finger stick, whole blood test
15 secondary outcomes
Delay in establishing adult Diabetes Care (gap in care>6 months)
Time frame: 24 months
Delay in establishing adult Diabetes Care (days)
Time frame: 24 months
Diabetes-related hospitalizations
Time frame: 0, 12, 24 months
Diabetes-related emergency department visits
Time frame: 0, 12, 24 months
Severe hypoglycemic events
Time frame: 0,12, 24 months
Stigma
Time frame: 0,12, 24 months
Self-efficacy
Time frame: 0,12, 24 months
Diabetes knowledge
Time frame: 0, 12, 24 months
Transition readiness
Time frame: 0, 12 months
Diabetes distress
Time frame: 0, 12, 24 months
Quality of life (Generic Core)
Time frame: 0, 12, 24 months
Quality of life (Diabetes Module)
Time frame: 0, 12, 24 months
Cost effectiveness (HbA1c)
Time frame: 12 and 24 months
Cost effectiveness (QOL)
Time frame: 12 and 24 months
Cost effectiveness (self-efficacy)
Time frame: 12 and 24 months
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 21 Nov 2024.
- Background: PubMed 29678801Brazeau AS, Nakhla M, Wright M, Henderson M, Panagiotopoulos C, Pacaud D, Kearns P, Rahme E, Da Costa D, Dasgupta K. Stigma and Its Association With Glycemic Control and Hypoglycemia in Adolescents and Young Adults With Type 1 Diabetes: Cross-Sectional Study. J Med Internet Res. 2018 Apr 20;20(4):e151. doi: 10.2196/jmir.9432.
- Background: PubMed 29650103Diabetes Canada Clinical Practice Guidelines Expert Committee; Wherrett DK, Ho J, Huot C, Legault L, Nakhla M, Rosolowsky E. Type 1 Diabetes in Children and Adolescents. Can J Diabetes. 2018 Apr;42 Suppl 1:S234-S246. doi: 10.1016/j.jcjd.2017.10.036. No abstract available.
- Background: PubMed 29632036Nakhla M, Rahme E, Simard M, Larocque I, Legault L, Li P. Risk of ketoacidosis in children at the time of diabetes mellitus diagnosis by primary caregiver status: a population-based retrospective cohort study. CMAJ. 2018 Apr 9;190(14):E416-E421. doi: 10.1503/cmaj.170676.
- Background: PubMed 29577410Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2.
- Background: PubMed 28761657Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.
- Background: PubMed 28747349Nakhla M, Rahme E, Simard M, Guttmann A. Outcomes associated with a pediatric clinical diabetes network in Ontario: a population-based time-trend analysis. CMAJ Open. 2017 Jul 24;5(3):E586-E593. doi: 10.9778/cmajo.20170022.
- Background: PubMed 27979791Brazeau AS, Nakhla M, Wright M, Panagiotopoulos C, Pacaud D, Henderson M, Rahme E, Da Costa D, Dasgupta K. Stigma and Its Impact on Glucose Control Among Youth With Diabetes: Protocol for a Canada-Wide Study. JMIR Res Protoc. 2016 Dec 15;5(4):e242. doi: 10.2196/resprot.6629.
- Background: PubMed 26498219Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.
- Background: PubMed 26210621Jefferies CA, Nakhla M, Derraik JG, Gunn AJ, Daneman D, Cutfield WS. Preventing Diabetic Ketoacidosis. Pediatr Clin North Am. 2015 Aug;62(4):857-71. doi: 10.1016/j.pcl.2015.04.002. Epub 2015 May 30.
- Background: PubMed 19933731Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.
- Background: PubMed 19500278Guttmann A, Nakhla M, Henderson M, To T, Daneman D, Cauch-Dudek K, Wang X, Lam K, Hux J. Validation of a health administrative data algorithm for assessing the epidemiology of diabetes in Canadian children. Pediatr Diabetes. 2010 Mar;11(2):122-8. doi: 10.1111/j.1399-5448.2009.00539.x. Epub 2009 Jun 5.
- Background: PubMed 18717235Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.
- Individual participant dataSharing planned: Yes. Individual participant data supporting the results reported in the published research articles, after de-identification will be available.
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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.
Meranda Nakhla, MD, MSc principal investigator
Montreal Children's Hospital - McGill University Health Centre (MUHC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active arm in people with Diabetes Mellitus, Type 1 and Type1diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites 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 2 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hemaglobin A1c (HbA1c) (time frame: 0, 12, 24 months). 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 NCT03703440, which also lists 13 linked publications.
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 21 Nov 2024.