The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.
Study Into the Use of a Diabetes Specialist Transition Nurse in the Care of Young People With Type 1 Diabetes Undergoing Transition From the Paediatric to the Adult Services, at the Northampton General Hospital
1 other identifier
interventional
100
1 country
1
Brief Summary
Study into the use of a diabetes specialist transition nurse in the care of young people aged 16-20 years, with type 1 diabetes; undergoing transition from the paediatric to the adult diabetes services at the Northampton General Hospital
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFebruary 15, 2021
February 1, 2021
2.9 years
August 22, 2019
February 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition
Rates of admission
3 years
Secondary Outcomes (5)
The mean Hba1C between the 2 study groups before and after transition
3 years
The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups
3 years
Emotional health of the 2 study groups
3 years
Emotional health of the 2 study groups
3 years
To compare the proportion of young people in the study groups who fail to attend at least one out-patient adult diabetes appointment during the first year after transition
3 years
Study Arms (2)
Transition intervention group
ACTIVE COMPARATORIntervention group -will be working with the specialist diabetes transition nurse. The nurse will follow a specific protocol involving visits, clinic support, community support and appointment rearranging. She will also maintain communication with the Hospital based adult and paediatric diabetes teams and the participants General Practitioner and relevant community health care professionals.
Post Transition group
PLACEBO COMPARATORThe previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.
Interventions
Support and on-going treatment intervention; monitoring the uptake of routine annual diabetes tests and encouraging to access where default observed General specialist diabetes support and provision of education and referral to other specialist healthcare agencies as individual requires
The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.
Eligibility Criteria
You may qualify if:
- established type 1 diabetes for minimum of 1 year
- attended the Northampton general Hospital, children's and young peoples diabetes service for at least 6 months prior to transition
- between the ages of 16 - 20 years
- ability to participate in all aspects of the trial
- written informed consent must be obtained
You may not qualify if:
- any condition which may interfere with the subjects ability to participate in the study including cystic-fibrosis related diabetes
- subjects who move away from the Northampton General Hospital clinic during the transition process
- those unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northampton general Hospital NHS Trust
Northampton, NN1 5BD, United Kingdom
Related Publications (2)
Crowley R, Wolfe I, Lock K, McKee M. Improving the transition between paediatric and adult healthcare: a systematic review. Arch Dis Child. 2011 Jun;96(6):548-53. doi: 10.1136/adc.2010.202473. Epub 2011 Mar 8.
PMID: 21388969RESULTSpaic T, Mahon JL, Hramiak I, Byers N, Evans K, Robinson T, Lawson ML, Malcolm J, Goldbloom EB, Clarson CL; JDRF Canadian Clinical Trial CCTN1102 Study Group. Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial). BMC Pediatr. 2013 Oct 9;13:163. doi: 10.1186/1471-2431-13-163.
PMID: 24106787RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne L Smith, MBChB
Northampton General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Paediatrician
Study Record Dates
First Submitted
August 22, 2019
First Posted
February 15, 2021
Study Start
December 1, 2018
Primary Completion
November 1, 2021
Study Completion
January 1, 2022
Last Updated
February 15, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share individual participant data, with other researchers