Diabetes in Primary Care - Improving Classification (DePICtion)

Diabetes in Primary Care - Improving Classification (DePICtion)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Qualitative interview (patients); Other: Qualitative interview (staff)

Detailed Description

Part 1:

Using a successful approach from previous research, and experience from existing online diabetes classification calculators, we will test the feasibility of developing a decision support tool that would run the algorithms in these calculators on electronic healthcare record data at participating GP sites. We will work with a company that will develop a decision support tool that will search and extract relevant healthcare data in GP systems, run our algorithms on these data, and produce a display, highlighting patient records where there is a potential misclassification of diabetes and/or records where there are potential data quality issues (e.g. mis-coding or missing information). The decision support tool will only run on extracted data (rather than being embedded in the GP system).

Participating GP sites will be offered an introductory education session on classification of diabetes subtypes and identification of MODY (Maturity Onset Diabetes of the Young) and training on running and interpreting the decision tool.

On receipt of the outputs from the decision support tool, practice staff will be advised to review the records of potentially misclassified patients to explore any mis-codings and to consider further testing/referrals as relevant and in line with the standard clinical care pathway for diabetes.

At the end of the study, the data extraction/decision support tool may be re-run to determine whether there have been changes and whether additional testing (eg C-peptide or islet autoantibody) or referral to a diabetes specialist team has been carried out.

Part 2:

To assess the acceptability of the diabetes classification tools to potential users, and to consider how best to implement them in clinical practice long term for maximum benefit, we will explore the views and experiences of general practice teams and people with diabetes on the use of the diabetes classification tools.

A sample of clinical and admin staff at participating GP sites, and diabetes patients flagged by the tool as misclassified, will be invited to take part in a semi-structured interview about their views & experience.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • Cornwall
    • Plymouth, Cornwall, United Kingdom, PL17 7AW
      • Tamar Valley Health
  • Devon
    • Ivybridge, Devon, United Kingdom, PL21 0AJ
      • Ivybridge Medical Practice (Beacon Medical Group)
    • Plymouth, Devon, United Kingdom, PL6 6PH
      • Roborough Surgery
    • Plymouth, Devon, United Kingdom, PL7 1AD
      • Pathfields Medical Group
    • Plymouth, Devon, United Kingdom, PL7 1AD
      • Plympton Health Centre (Beacon Medical Group)
    • Plymouth, Devon, United Kingdom, PL7 2QP
      • Chaddlewood Surgery (Beacon Medical Group)
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1NA
      • Hucknall Road Medical Centre
    • Nottingham, Nottinghamshire, United Kingdom, NG6 8QJ
      • Parkside Medical Practice
    • Nottingham, Nottinghamshire, United Kingdom, NG9 6DX
      • Chilwell Valley and Meadows Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Eligibility criteria for qualitative interviews.

Inclusion Criteria:

Patients

• Able to give written informed consent
• 18 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
• 18 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)

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients qualitative interviews; Patients reviewed by their GP as a result of Stage 1 (running of tool) are invited to a qualitative interview.; Consenting participants interviewed by the research team.; Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.	Other: Qualitative interview (patients); 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.
Practice staff qualitative interviews; Practice staff (clinical and administrative) who have been involved in Stage 1 (running of tool) are invited to a qualitative interview.; Consenting participants interviewed by the research team.; Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.	Other: Qualitative interview (staff); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of acceptability of the DePICtion Tool	Semi-structured, one-to-one interviews with staff and patients to evaluate (A) experiences of implementing the tool in this study and (B) views regarding the use of a diabetes classification tool in primary care in the future, including the impact and potential benefits.	Interviews to be conducted from 2 weeks to 6 months after implementing the tool in practice.

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: University of Nottingham; University of Bristol; National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Beverley Shields, Professor, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): March 5, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2022-23-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No