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

NHS Trust

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: Transition intervention group; Other: Post transition group

Study type: Interventional

Funder types: Other

Identifiers

NCT04754919

10087 (Other Identifier)

Details and patient eligibility

About

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

Full 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?

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 20 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Transition intervention group

Active Comparator group

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.

Treatment:

Other: Transition intervention group

Post Transition group

Placebo Comparator group

Description:

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

Treatment:

Other: Post transition group