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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04754919
• Other study ID #: 10087
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: Northampton General Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Northampton general Hospital NHS Trust	Northampton

Sponsors (1)

Lead Sponsor	Collaborator
Northampton General Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. Review. — View 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 com — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The mean Hba1C between the 2 study groups before and after transition	Hba1C measurement	3 years
Secondary	The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups	Annual diabetes routine checks	3 years
Secondary	Emotional health of the 2 study groups	HADS Questionnaire	3 years
Secondary	Emotional health of the 2 study groups	PAID Questionnaire	3 years
Secondary	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	Compare attendance rates	3 years

External Links

•   Hospital Anxiety and Depression Scale
•   National Institute for Health and Care Excellence guidance adults
•   National Institute for Health and Care Excellence guidance for children and young people
•   Problem Areas in Diabetes Questionaire