Type 1 Diabetes MellitusNCT04754919
The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.
A study testing Transition intervention group and Post transition group in people with Type 1 Diabetes Mellitus, run by Northampton General Hospital NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Transition intervention group and Post transition group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2018to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Northampton general Hospital NHS Trust
Northampton, NN1 5BD
About this study
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 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
Read the 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?
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Transition intervention group, Post transition group
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition intervention groupOther
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 groupOther
The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Transition intervention group | Active comparator | 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. Receives: Other: Transition intervention group |
| Post Transition group | Placebo comparator | The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group. Receives: Other: Post transition group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition
Rates of admission
Measured: 3 years
Secondary outcomes (5)
The mean Hba1C between the 2 study groups before and after transition
Hba1C measurement
Measured: 3 years
The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups
Annual diabetes routine checks
Measured: 3 years
Emotional health of the 2 study groups
HADS Questionnaire
Measured: 3 years
Emotional health of the 2 study groups
PAID Questionnaire
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Dec 2018
- Primary completionNov 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Next 50 eligible young people entering transition
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northampton General Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anne Smith, Northampton General Hospital NHS Trust
- Investigators
- Anne L Smith, MBChB, Principal investigator, Northampton General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754919
- Sponsor's protocol ID
- 10087
- Status last verified
- Feb 2021
- First submitted
- 22 Aug 2019
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data, with other researchers
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.
PubMed 21388969Spaic 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.
PubMed 24106787
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04754919
- Acronym / sponsor ID
- 10087
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northampton General Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Next 50 eligible young people entering transition
| Arm | Type | Receives |
|---|---|---|
| Transition intervention group | Active comparator | Other: Transition intervention groupIntervention 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. |
| Post Transition group | Placebo comparator | Other: Post transition groupThe previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition intervention groupSupport 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 | Other | Transition intervention group |
| Post transition groupThe previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group. | Other | Post Transition group |
Primary outcome
The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition
Time frame: 3 years
Rates of admission
5 secondary outcomes
The mean Hba1C between the 2 study groups before and after transition
Time frame: 3 years
The frequency of testing according to National Institute for Health and Care Excellence between the 2 study groups
Time frame: 3 years
Emotional health of the 2 study groups
Time frame: 3 years
Emotional health of the 2 study groups
Time frame: 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
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Results publication: PubMed 21388969Crowley 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 publication: PubMed 24106787Spaic 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.
- National Institute for Health and Care Excellence guidance adultsLink provided by the sponsor.
- National Institute for Health and Care Excellence guidance for children and young peopleLink provided by the sponsor.
- Problem Areas in Diabetes QuestionaireLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data, with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne L Smith, MBChB principal investigator
Northampton General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition intervention group and Post transition group in people with Type 1 Diabetes Mellitus, run by Northampton General Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rates of diabetes related hospital episodes, including Diabetic Ketoacidosis, between the 2 study groups before and after transition (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.