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

Primary Purpose

Diabetes Complications, Diabetes Mellitus, Type 1, Diabetic Neuropathies

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hybrid Closed Loop Insulin Pump
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manchester Diabetes Centre, Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

MDI

Artificial Pancreas - Closed Loop

Arm Description

All participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests

All participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests

Outcomes

Primary Outcome Measures

1. Change in Corneal nerve fibre density (CNFD)
Corneal nerve fibre density (CNFD)

Secondary Outcome Measures

Neuropathy symptom profile
Symptoms of painful neuropathy measured using the neuropathic pain symptom inventory scale
Neuropathy disability score
Neuropathy disability score
Quality of life questionnaire
Quality of life Short Form -36 scale measurement

Full Information

First Posted
March 16, 2023
Last Updated
July 10, 2023
Sponsor
Manchester University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05951283
Brief Title
Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy
Acronym
QUANT-AP
Official Title
A Longitudinal, Single Centre Study to Assess the Effects of Artificial Pancreas-related Changes in Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications, Diabetes Mellitus, Type 1, Diabetic Neuropathies
Keywords
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MDI
Arm Type
No Intervention
Arm Description
All participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests
Arm Title
Artificial Pancreas - Closed Loop
Arm Type
Active Comparator
Arm Description
All participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests
Intervention Type
Device
Intervention Name(s)
Hybrid Closed Loop Insulin Pump
Intervention Description
As above
Primary Outcome Measure Information:
Title
1. Change in Corneal nerve fibre density (CNFD)
Description
Corneal nerve fibre density (CNFD)
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Neuropathy symptom profile
Description
Symptoms of painful neuropathy measured using the neuropathic pain symptom inventory scale
Time Frame
6 and 12 months. Min value 0, max value 38. Higher score suggests a worse outcome
Title
Neuropathy disability score
Description
Neuropathy disability score
Time Frame
6 and 12 months Min value 0, max value 10. Higher score suggests a worse outcome
Title
Quality of life questionnaire
Description
Quality of life Short Form -36 scale measurement
Time Frame
6 and 12 months Min value 0, max value 36. Higher score suggests a worse outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Nazir
Phone
01612766706
Email
Mohammed.Nazir@mft.nhs.uK
Facility Information:
Facility Name
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy

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