Diabetes ComplicationsQUANT-APNCT05951283
Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy
A study testing Hybrid Closed Loop Insulin Pump in people with Diabetes Complications and Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Complications, Diabetes Mellitus, Type 1, Diabetic Neuropathies
- What is being tested?
- Hybrid Closed Loop Insulin Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2023to 1 Jul 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: 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.
Read more
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.
- Being tested
- Hybrid Closed Loop Insulin Pump
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Type 1, Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Closed Loop Insulin PumpDevice
As above
| Study group | Role | What they receive |
|---|---|---|
| MDI | No intervention | All participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests |
| Artificial Pancreas - Closed Loop | Active comparator | All participants will have:
Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests Receives: Device: Hybrid Closed Loop Insulin Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in Corneal nerve fibre density (CNFD)
Corneal nerve fibre density (CNFD)
Measured: 6 and 12 months
Secondary outcomes (3)
Neuropathy symptom profile
Symptoms of painful neuropathy measured using the neuropathic pain symptom inventory scale
Measured: 6 and 12 months. Min value 0, max value 38. Higher score suggests a worse outcome
Neuropathy disability score
Neuropathy disability score
Measured: 6 and 12 months Min value 0, max value 10. Higher score suggests a worse outcome
Quality of life questionnaire
Quality of life Short Form -36 scale measurement
Measured: 6 and 12 months Min value 0, max value 36. Higher score suggests a worse outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951283
- Sponsor's protocol ID
- B01841
- Acronym
- QUANT-AP
- Status last verified
- Oct 2023
- First submitted
- 16 Mar 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Single Centre Study to Assess the Effects of Artificial Pancreas-related Changes in Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05951283
- Acronym / sponsor ID
- QUANT-AP / B01841
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 19 Jul 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDI | No intervention | –All participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests |
| Artificial Pancreas - Closed Loop | Active comparator | Device: Hybrid Closed Loop Insulin PumpAll participants will have: Continuous Glucose Monitoring Neuropathy Assessments and Pain Questionnaires ACR, Blood Tests |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Hybrid Closed Loop Insulin PumpAs above | Device | Artificial Pancreas - Closed Loop |
Primary outcome
1. Change in Corneal nerve fibre density (CNFD)
Time frame: 6 and 12 months
Corneal nerve fibre density (CNFD)
3 secondary outcomes
Neuropathy symptom profile
Time frame: 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
Quality of life questionnaire
Time frame: 6 and 12 months Min value 0, max value 36. Higher score suggests a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Closed Loop Insulin Pump in people with Diabetes Complications and Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation 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 2 inclusion and 5 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 30 Oct 2023. 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. 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?
Contact Mohammed Nazir (01612766706, Mohammed.Nazir@mft.nhs.uK), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change in Corneal nerve fibre density (CNFD) (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2023.