The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.

Not Applicable

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Transition intervention group; Other: Post transition group

• Registration Number: NCT04754919
• Lead Sponsor: Northampton General Hospital NHS Trust

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?

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-08-22
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Study First Posted: 2021-02-15
• Last Update Posted: 2021-02-15
• Primary Completion: 2021-11
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transition intervention group	Transition intervention group	Intervention 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	Post transition group	The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.

Primary Outcome Measures

Name	Time	Method
The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition	3 years	Rates of admission

Secondary Outcome Measures

Name	Time	Method
The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups	3 years	Annual diabetes routine checks
Emotional health of the 2 study groups	3 years	PAID Questionnaire
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	Compare attendance rates
The mean Hba1C between the 2 study groups before and after transition	3 years	Hba1C measurement

Trial Locations

Locations (1)

Northampton general Hospital NHS Trust; 🇬🇧 Northampton, United Kingdom