Clinical trial NCT04754919: The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Northampton General Hospital NHS Trust
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Next 50 eligible young people entering transition
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Does the use of a structured diabetes transition program in the care of young people transitioning from the paediatric to the adult diabetes services at Northampton General Hospital improve the study group mean HbA1C, reduce the number of diabetes related hospital episodes and increase attendance at the adult diabetes clinic following transition to the adult service?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition
timeFrame: 3 years
Secondary outcomes:
measure: The mean Hba1C between the 2 study groups before and after transition
timeFrame: 3 years
measure: The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups
timeFrame: 3 years
measure: Emotional health of the 2 study groups
timeFrame: 3 years
measure: Emotional health of the 2 study groups
timeFrame: 3 years
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Northampton
country: United Kingdom
facility: Northampton general Hospital NHS Trust
Study officials:
affiliation: Northampton General Hospital
name: Anne L Smith, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Spaic 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.