Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy (QUANT-AP)

October 27, 2023 updated by: Manchester University NHS Foundation Trust

A Longitudinal, Single Centre Study to Assess the Effects of Artificial Pancreas-related Changes in Diabetic Neuropathy

A complication of diabetes mellitus is damage to nerves called neuropathy. There are several mechanisms involved that will lead to the development of neuropathy. Neuropathy can lead to foot ulcers, infections and amputations. Patients with neuropathy may also experience pain, which can be difficult to control and the medications are limited by side effects. Despite this there are no approved treatments to reverse the progression of neuropathy and the management of patients is focused on controlling blood glucose and other metabolic factors to prevent neuropathy and its symptoms from getting worse.

Patients with type 1 diabetes are prescribed multiple daily injections (MDI) of insulin to manage their glucose control. However, insulin pump therapy and, more recently, automated insulin delivery (AID) or the Artificial Pancreas can be used as the insulin delivery method for patients with type 1 diabetes mellitus. Manchester Diabetes Centre is the first adult diabetes centre in Europe to pioneer and use a commercially-approved AID in clinical practice.

Insulin pump therapy and AID have the advantage of being able to provide insulin at variable doses, which is closer to the natural process occurring within an individual without diabetes. Both are currently considered to be the most physiological method of insulin delivery and have been shown to improve glycaemic control, quality of life (QOL) and reduce the risk of hypoglycaemia (low blood glucose level). The investigators have previously shown in a small group of people that use of an insulin pump therapy may improve symptoms of painful neuropathy via a more stable glucose profile. The peaks and drops in insulin may make neuropathy worse.

In this study the investigators aim to investigate the use of insulin pump therapy and AID in their effect on neuropathy. This will be in comparison to a control group of patients on MDI. The investigatorsbwill use a variety of neuropathy measures and symptom questionnaires to assess structural and functional neuropathy status. The investigators hypothesise that those patients receiving the newer technologies will demonstrate an improvement in symptoms and nerve regeneration.

This finding would have a significant impact for patients as it would provide evidence to suggest that those patients with neuropathy should be put onto an insulin pump or AID to improve neuropathy and its symptoms. As these are treatments that are already available on the NHS to patients satisfying specific criteria this study aims to show benefit in this cohort of patients which can be implemented immediately in clinical practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester Diabetes Centre, Manchester University NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Type 1 diabetes aged 18-70 who falls into either of these three categories and has the ability to read and comprehend English:

Starting Artificial Pancreas therapy as determined for clinical need Starting insulin pump therapy as determined for clinical need On multiple daily injection therapy for insulin delivery

Exclusion Criteria:

  • History of ocular disease that may affect the cornea.
  • History of corneal trauma or surgery (NB cataract surgery does not preclude enrolment unless surgery occurred in the 3 months prior to enrolment date)
  • Concurrent ocular disease, infection or inflammation.
  • History of neuropathy due to alcoholism, renal impairment requiring renal replacement therapy, infectious disease (e.g., Lyme disease, HIV/AIDS, hepatitis B), liver failure, B12 deficiency
  • Unable to read and comprehend English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: MDI

All participants will have:

Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests
Active Comparator: Artificial Pancreas - Closed Loop

All participants will have:

Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests
Device: Hybrid Closed Loop Insulin Pump
As above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Change in Corneal nerve fibre density (CNFD)
Time Frame: 6 and 12 months
Corneal nerve fibre density (CNFD)
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathy symptom profile
Time Frame: 6 and 12 months. Min value 0, max value 38. Higher score suggests a worse outcome
Symptoms of painful neuropathy measured using the neuropathic pain symptom inventory scale
6 and 12 months. Min value 0, max value 38. Higher score suggests a worse outcome
Neuropathy disability score
Time Frame: 6 and 12 months Min value 0, max value 10. Higher score suggests a worse outcome
Neuropathy disability score
6 and 12 months Min value 0, max value 10. Higher score suggests a worse outcome
Quality of life questionnaire
Time Frame: 6 and 12 months Min value 0, max value 36. Higher score suggests a worse outcome
Quality of life Short Form -36 scale measurement
6 and 12 months Min value 0, max value 36. Higher score suggests a worse outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B01841

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Complications

Clinical Trials on Hybrid Closed Loop Insulin Pump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe