Diabetes in Primary Care - Improving Classification

NCT06711718 | Completed

• 1 other identifier: 2022-23-18
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 9

Brief Summary

This study aims to evaluate the clinical utility and acceptability to patients and practitioners of running diabetes classification algorithms on primary care data to help improve diagnosis of diabetes subtypes in adults diagnosed with diabetes under the age of 50. The outputs from this research will help provide initial data on how best to use these algorithms in primary care and the optimal design of a decision support tool that could be taken forward to a full trial.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number and Proportion of patients flagged by the tool

  Number and Proportion of patients flagged by the tool at each practice. Mean number of patients flagged by the tool across the practices.

  Months 12-18.

Secondary Outcomes (1)

• Assessment of acceptability of the DePICtion Tool

  Interviews to be conducted from 2 weeks to 6 months after implementing the tool in practice.

Study Arms (2)

Patients qualitative interviews

1. Patients reviewed by their GP as a result of Stage 1 (running of tool) are invited to a qualitative interview. 2. Consenting participants interviewed by the research team. 3. Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.

Other: Qualitative interview (patients)

Practice staff qualitative interviews

1. Practice staff (clinical and administrative) who have been involved in Stage 1 (running of tool) are invited to a qualitative interview. 2. Consenting participants interviewed by the research team. 3. Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.

Other: Qualitative interview (staff)

Interventions

Qualitative interview (patients) OTHER

Qualitative interviews to be carried out by an experienced researcher with patients who have had their diabetes diagnosis reviewed as a result of the running of the tool.

Patients qualitative interviews

Qualitative interview (staff) OTHER

Qualitative interviews to be carried out by an experienced researcher with practice staff who have run the tool and reviewed patients flagged by the tool.

Practice staff qualitative interviews

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a review of their diabetes diagnosis as a result of the running of the tool will be invited to interview. Clinical practice staff (GP and/or nurse) who have been involved in reviewing patients flagged following running of the tool will be invited to interview. Practice Manager or administrator who has run the searches and tool will be invited to interview.

You may qualify if:

• Patients
• Able to give written informed consent
• years of age or over at the time of study participation
• Diabetes diagnosed at or under the age of 50
• Registered with a participating GP practice
• Sufficient understanding of the English Language to enable completion of the interview
• Staff
• Able to give written informed consent
• years of age or over
• Working at a participating General Practice and directly involved with the study procedures (eg running the decision support tool, responsibility for clinical care of diabetes patients)

You may not qualify if:

• Patients
• Unable to give written informed consent
• Under 18 years of age
• No diabetes or diabetes diagnosed over the age of 50.
• Not registered with a participating GP practice
• Insufficient understanding of the English Language to enable interview completion
• Have an opt-out code where patient has declined electronic medical records examined
• Considered by their General Practitioner(s) to be inappropriate to recruit due to psycho-social reasons, participating in another related clinical trial or significant health reasons, e.g. terminal illness/diagnosis.
• Staff
• Unable to give written informed consent
• Under 18 years of age
• General Practice staff not involved with the study procedures.

Sponsors & Collaborators

• University of Exeter: lead
• University of Bristol: collaborator
• University of Nottingham: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (9)

Tamar Valley Health

Plymouth, Cornwall, PL17 7AW, United Kingdom

Location

Ivybridge Medical Practice (Beacon Medical Group)

Ivybridge, Devon, PL21 0AJ, United Kingdom

Location

Roborough Surgery

Plymouth, Devon, PL6 6PH, United Kingdom

Location

Pathfields Medical Group

Plymouth, Devon, PL7 1AD, United Kingdom

Location

Plympton Health Centre (Beacon Medical Group)

Plymouth, Devon, PL7 1AD, United Kingdom

Location

Chaddlewood Surgery (Beacon Medical Group)

Plymouth, Devon, PL7 2QP, United Kingdom

Location

Hucknall Road Medical Centre

Nottingham, Nottinghamshire, NG5 1NA, United Kingdom

Location

Parkside Medical Practice

Nottingham, Nottinghamshire, NG6 8QJ, United Kingdom

Location

Chilwell Valley and Meadows Practice

Nottingham, Nottinghamshire, NG9 6DX, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Beverley Shields, Professor

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: December 2, 2024
• Study Start: June 25, 2024
• Primary Completion: March 5, 2026
• Study Completion: March 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

GB (9)