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

NCT ID: NCT04754919

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-01-31

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?

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Next 50 eligible young people entering transition
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transition intervention group

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Post transition group

Intervention Type OTHER

The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.

Interventions

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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

Intervention Type OTHER

Post transition group

The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.

Intervention Type OTHER

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northampton General Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr Anne Smith

Consultant Paediatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne L Smith, MBChB

Role: PRINCIPAL_INVESTIGATOR

Northampton General Hospital

Locations

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Northampton general Hospital NHS Trust

Northampton, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 21388969 (View on PubMed)

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.

Reference Type RESULT
PMID: 24106787 (View on PubMed)

Related Links

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http://www.nice.org.uk/guidance/ng17

National Institute for Health and Care Excellence guidance adults

http://www.nice.org.uk/guidance/ng18

National Institute for Health and Care Excellence guidance for children and young people

Other Identifiers

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10087

Identifier Type: -

Identifier Source: org_study_id

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