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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Transition intervention group; Other: Post transition group

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Northampton, United Kingdom, NN1 5BD
    • Northampton General Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Placebo Comparator: Post Transition group; The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.	Other: Post transition group; The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northampton General Hospital NHS Trust
• Investigators: Principal Investigator: Anne L Smith, MBChB, Northampton General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• National Institute for Health and Care Excellence guidance adults
• National Institute for Health and Care Excellence guidance for children and young people
• Hospital Anxiety and Depression Scale

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 10087 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share individual participant data, with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No