Group Education Trial to Improve Transition in Type 1 Diabetes

NCT03703440 | Completed

• 1 other identifier: MP-37-2019-4434
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 1; Type1diabetes; Insulin Dependent Diabetes

Keywords

Transition care; Pediatric; Adolescent; Education; Hemaglobin A1c; Health Services; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Hemaglobin A1c (HbA1c)

  HbA1c will be measured using an A1c Test Kit, which is a non-fasting, finger stick, whole blood test

  0, 12, 24 months

Secondary Outcomes (15)

• Delay in establishing adult Diabetes Care (gap in care>6 months)

  24 months

• Delay in establishing adult Diabetes Care (days)

  24 months

• Diabetes-related hospitalizations

  0, 12, 24 months

• Diabetes-related emergency department visits

  0, 12, 24 months

• Severe hypoglycemic events

  0,12, 24 months

Study Arms (2)

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.

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.

Other: Control arm

Interventions

Active arm OTHER

≥3 group education sessions in addition to usual diabetes care, every 3 months for 12 months

Active

Control arm OTHER

Usual diabetes care, every 3-month for 12 months

Control

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents with a diagnosis of Type 1 Diabetes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• St. Justine's Hospital: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Centre Hospitalier Universitaire Sainte-Justine (CHUSJ)

Montreal, Quebec, H3T 1C5, Canada

Location

Montreal Children's Hospital - McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (13)

• 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.

  PMID: 29678801 BACKGROUND

• Diabetes 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.

  PMID: 29650103 BACKGROUND

• Nakhla 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.

  PMID: 29632036 BACKGROUND

• Michaud 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.

  PMID: 29577410 BACKGROUND

• Nakhla 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.

  PMID: 28761657 BACKGROUND

• Nakhla 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.

  PMID: 28747349 BACKGROUND

• Brazeau 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.

  PMID: 27979791 BACKGROUND

• Wafa 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.

  PMID: 26498219 BACKGROUND

• Jefferies 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.

  PMID: 26210621 BACKGROUND

• Nakhla 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.

  PMID: 19933731 BACKGROUND

• Guttmann 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.

  PMID: 19500278 BACKGROUND

• Nakhla 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.

  PMID: 18717235 BACKGROUND

• Mok 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.

  PMID: 31719096 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Meranda Nakhla, MD, MSc

  Montreal Children's Hospital - McGill University Health Centre (MUHC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: November 19, 2019
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available immediately following article publication and ending 5 years after article publication.
• Access Criteria: Data will be shared with researchers who provide a scientifically sound proposal that has been approved by an independent Institutional Review Board and for analyses that addresses the aims specified in the proposal (e.g. for individual participant data meta-analysis). Proposals should be submitted to meranda.nakhla@mcgill.ca. Data requestors will need to sign a data access agreement. Data will be available up to 5 years following article publication at (Link to be included).

Locations

CA (2)