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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transition intervention group
Post transition group
Sponsored by
Northampton General Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus

Eligibility Criteria

16 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northampton general Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Transition intervention group

Post Transition group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2019
Last Updated
February 12, 2021
Sponsor
Northampton General Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04754919
Brief Title
The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northampton General Hospital NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Next 50 eligible young people entering transition
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transition intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Post Transition group
Arm Type
Placebo Comparator
Arm Description
The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.
Intervention Type
Other
Intervention Name(s)
Transition intervention group
Intervention Description
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
Intervention Name(s)
Post transition group
Intervention Description
The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.
Primary Outcome Measure Information:
Title
The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition
Description
Rates of admission
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The mean Hba1C between the 2 study groups before and after transition
Description
Hba1C measurement
Time Frame
3 years
Title
The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups
Description
Annual diabetes routine checks
Time Frame
3 years
Title
Emotional health of the 2 study groups
Description
HADS Questionnaire
Time Frame
3 years
Title
Emotional health of the 2 study groups
Description
PAID Questionnaire
Time Frame
3 years
Title
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
Description
Compare attendance rates
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne L Smith, MBChB
Organizational Affiliation
Northampton General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northampton general Hospital NHS Trust
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data, with other researchers
Citations:
PubMed Identifier
21388969
Citation
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.
Results Reference
result
PubMed Identifier
24106787
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 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.
Results Reference
result
Links:
URL
http://www.nice.org.uk/guidance/ng17
Description
National Institute for Health and Care Excellence guidance adults
URL
http://www.nice.org.uk/guidance/ng18
Description
National Institute for Health and Care Excellence guidance for children and young people
URL
https://academic.oup.com
Description
Hospital Anxiety and Depression Scale

Learn more about this trial

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

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