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

Study Overview
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Brief Summary
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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
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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?

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Transition intervention group
* Other: Post transition group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Next 50 eligible young people entering transition
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |