Diabetes MellitusNCT01908530
Clinical Assessment of a Novel Microprobe Array Continuous Glucose Monitor for Type 1 Diabetes
A study testing Microprobe glucose sensor in people with Diabetes Mellitus, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess the safety and efficacy of the Imperial College Microprobe Array Continuous Glucose Sensor in healthy volunteers and in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Microprobe glucose sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age
- Adults over 18 years of age.
- Diagnosed with Type 1 diabetes for greater than 1 year.
- HbA1c less than or equal to 9.0 % (75 mmol/mol).
- Registered with a General Practitioner.
Who cannot join
- History of upper limb neuropathy or radiculopathy
- History of pre-existing skin condition
- Pregnant or planning pregnancy in next 12 months
- Breastfeeding
- Enrolled in other clinical trials
- uncontrolled concurrent illness
Show all 16Show fewer
- Have active malignancy or under investigation for malignancy
- For phases 3 and 4:
- History of diabetic dermopathy or pre-existing skin condition
- History of upper limb neuropathy or radiculopathy
- Pregnant or planning pregnancy in next 12 months
- Breastfeeding
- Enrolled in other clinical trials
- uncontrolled concurrent illness
- physical or visual impairment preventing sensor's use
- Have active malignancy or under investigation for malignancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to assess the safety and efficacy of the Imperial College Microprobe Array Continuous Glucose Sensor in healthy volunteers and in subjects with type 1 diabetes.
Read the detailed description
Continuous knowledge of ambient glucose levels will be of benefit to patients with T1DM, especially those with troublesome hypoglycaemia. Existing monitors require skin puncture to access interstitial fluid and sense its glucose content. Despite their clinical benefits, their use is associated with discomfort and their accuracy is questionable in hypoglycaemia. The development of a painless continuous glucose monitor is regarded as the top research priority by patients with diabetes. A novel continuous glucose monitoring device has been developed at Imperial College based on microprobe technology. It consists of a small, wearable patch (~1 cm2), the size of a conventional postage stamp, containing microscopic projections (microprobes) that penetrate only the outermost skin layer. It accesses interstitial fluid to sense its glucose content without stimulating skin nerve fibres or reaching blood vessels within skin layers. The microprobe surface has the consistency of sandpaper. It is pushed into the skin with an applicator allowing it to penetrate through the skin layers and access the interstitial fluid in a minimally invasive manner. The device is disposable and optimum performance will be assessed over five days. The advantages of microprobe technology have been demonstrated in other clinical situations and include painless insertion, absence of bleeding and a low infection risk. The large surface area utilised in our microprobe device has the potential to improve device sensitivity and accuracy. Pre-clinical validation tests have demonstrated the ability of the device to respond accurately to variable glucose concentrations and to penetrate the outermost skin layer without fracture. We aim now to further develop the device through clinical studies in non-diabetic subjects and subjects with type 1 diabetes to allow painless accurate continuous glucose monitoring.
The study will recruit 16 non-diabetic subjects and 20 subjects with type 1 diabetes.
It will be conducted over four phases;
oPhase 1 will assess safety, as a primary outcome, and efficacy, as a secondary outcome, in non-diabetic subjects over six hours in the clinical research facility where the device will be fitted and a cannula inserted for venous sampling every 15 minutes to measure venous blood glucose (YSI). Safety will be assessed with regards to skin inflammation and pain. Efficacy will be assessed in this phase by assessing magnitude of current measured by the microprobe array sensor and comparison of measured ISF glucose concentrations to simultaneous venous blood glucose samples (YSI).
oPhase 2 will also assess safety, as a primary outcome, and efficacy, as a secondary outcome, in non-diabetic subjects over a period of 24 hours. The first six hours in the clinical research facility (same as phase 1), then subject will be allowed to go home with the device to assess safety over that period.
oPhase 3 aims to assess efficacy of the device as a primary outcome and safety as a secondary outcome. This will be in subjects with type 1 diabetes over 24 hours as inpatients. Efficacy will be assessed mechanically (by the ability to penetrate the stratum corneum) and functionally (by the ability to accurately sense ISF glucose). The derived ISF glucose levels will be compared with simultaneous venous glucose samples (YSI) and with a commercially available CGM device (iPro2, Medtronic). Assessment of microprobe penetration of the stratum corneum will be performed using confocal microscopy, optical coherence tomography and in skin biopsies.
oPhase 4 aims to assess efficacy of the device as a primary outcome and safety as a secondary outcome. This will be in subjects with type 1 diabetes over 5 days in ambulatory situation. Efficacy will be assessed by comparing microprobe sensor derived ISF glucose levels against ISF glucose levels measured using a commercially available CGM device (iPro2, Medtronic).
- Conditions
- Diabetes Mellitus
- Being tested
- Microprobe glucose sensor
- Keywords
- Diabetes, Continuous Glucose Monitoring, Microprobes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microprobe glucose sensorDevice
Also called Microprobe Array Continuous Glucose Monitor
Assessment of safety and accuracy of a novel continuous glucose monitor based on microprobe technology.
| Study group | Role | What they receive |
|---|---|---|
| Microprobe Glucose Sensor Phase 1 | Experimental | The microprobe array continuous glucose sensor will be applied to healthy volunteers for 6 hours Receives: Device: Microprobe glucose sensor |
| Microprobe Glucose Sensor Phase 2 | Experimental | The microprobe array continuous glucose sensor will be applied to healthy volunteers for 24 hours Receives: Device: Microprobe glucose sensor |
| Microprobe Glucose Sensor Phase 3 and 4 | Experimental | The microprobe array continuous glucose sensor will be applied to participants with type 1 diabetes Receives: Device: Microprobe glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Developed the Skin Inflammation
The study aims to assess safety of the use of microprobe array continuous glucose sensor with regards to skin inflammation.
Measured: 24 hours
Difference to the Venous Blood Glucose MARD
Phase 3 of the study aim to assess efficacy of the device in people with type 1 diabetes. This will be done in comparison to venous blood glucose using YSI machine in a controlled environment over 24 hours (phase 3). it was originally planned to then compare this to ISF glucose in ambulatory situation over five days (phase 4) however phase 4 did not go ahead. Measured using mean absolute relative difference with respect to venous blood glucose
Measured: 24 hours
Secondary outcomes (5)
Pain Score
The study aims to assess safety of the device with regards to pain degree in comparison to venflon insertion and insertion of an existing continuous glucose monitor (Medtronic iPro2 CGM system, Northridge, California). This will be done at each phase of the four study phases.
Measured: 24 hours
Number of Participant Developed Skin Penetration
This done using Optical Coherence Tomography and Confocal Microscopy. Measure = variation in penetration depth of microprobe needles over 24 hours
Measured: 24 hours
Detectable Signal
This is a secondary outcome for phases 1 \& 2.
Measured: 24 hours
Correlation With Venous Blood Glucose
This is a secondary outcome for phases 1 and 2. It is a primary outcome for phase 3. Using MARD.
Measured: 24 hours
Acceptability Questionnaire
This is a secondary outcome for phases 3 and 4.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Desmond Johnston, PhD, FRCP, Principal investigator, Professor of Diabetes & Endocrinology - Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908530
- Sponsor's protocol ID
- 13SM0639
- Status last verified
- Oct 2019
- First submitted
- 23 Jul 2013
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Laboudi A, Oliver NS, Cass A, Johnston D. Use of microneedle array devices for continuous glucose monitoring: a review. Diabetes Technol Ther. 2013 Jan;15(1):101-15. doi: 10.1089/dia.2012.0188. Epub 2012 Dec 12.
PubMed 23234256Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
PubMed 21737469Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011 Apr;34(4):795-800. doi: 10.2337/dc10-1989. Epub 2011 Feb 19.
PubMed 21335621Khanna P, Strom JA, Malone JI, Bhansali S. Microneedle-based automated therapy for diabetes mellitus. J Diabetes Sci Technol. 2008 Nov;2(6):1122-9. doi: 10.1177/193229680800200621.
PubMed 19885301Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
PubMed 18779236
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Novel Microprobe Array Continuous Glucose Monitor for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01908530
- Acronym / sponsor ID
- 13SM0639
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Continuous Glucose Monitoring, Microprobes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety and efficacy of the Imperial College Microprobe Array Continuous Glucose Sensor in healthy volunteers and in subjects with type 1 diabetes.
Detailed description
Continuous knowledge of ambient glucose levels will be of benefit to patients with T1DM, especially those with troublesome hypoglycaemia. Existing monitors require skin puncture to access interstitial fluid and sense its glucose content. Despite their clinical benefits, their use is associated with discomfort and their accuracy is questionable in hypoglycaemia. The development of a painless continuous glucose monitor is regarded as the top research priority by patients with diabetes. A novel continuous glucose monitoring device has been developed at Imperial College based on microprobe technology. It consists of a small, wearable patch (~1 cm2), the size of a conventional postage stamp, containing microscopic projections (microprobes) that penetrate only the outermost skin layer. It accesses interstitial fluid to sense its glucose content without stimulating skin nerve fibres or reaching blood vessels within skin layers. The microprobe surface has the consistency of sandpaper. It is pushed into the skin with an applicator allowing it to penetrate through the skin layers and access the interstitial fluid in a minimally invasive manner. The device is disposable and optimum performance will be assessed over five days. The advantages of microprobe technology have been demonstrated in other clinical situations and include painless insertion, absence of bleeding and a low infection risk. The large surface area utilised in our microprobe device has the potential to improve device sensitivity and accuracy. Pre-clinical validation tests have demonstrated the ability of the device to respond accurately to variable glucose concentrations and to penetrate the outermost skin layer without fracture. We aim now to further develop the device through clinical studies in non-diabetic subjects and subjects with type 1 diabetes to allow painless accurate continuous glucose monitoring.
The study will recruit 16 non-diabetic subjects and 20 subjects with type 1 diabetes.
It will be conducted over four phases;
oPhase 1 will assess safety, as a primary outcome, and efficacy, as a secondary outcome, in non-diabetic subjects over six hours in the clinical research facility where the device will be fitted and a cannula inserted for venous sampling every 15 minutes to measure venous blood glucose (YSI). Safety will be assessed with regards to skin inflammation and pain. Efficacy will be assessed in this phase by assessing magnitude of current measured by the microprobe array sensor and comparison of measured ISF glucose concentrations to simultaneous venous blood glucose samples (YSI).
oPhase 2 will also assess safety, as a primary outcome, and efficacy, as a secondary outcome, in non-diabetic subjects over a period of 24 hours. The first six hours in the clinical research facility (same as phase 1), then subject will be allowed to go home with the device to assess safety over that period.
oPhase 3 aims to assess efficacy of the device as a primary outcome and safety as a secondary outcome. This will be in subjects with type 1 diabetes over 24 hours as inpatients. Efficacy will be assessed mechanically (by the ability to penetrate the stratum corneum) and functionally (by the ability to accurately sense ISF glucose). The derived ISF glucose levels will be compared with simultaneous venous glucose samples (YSI) and with a commercially available CGM device (iPro2, Medtronic). Assessment of microprobe penetration of the stratum corneum will be performed using confocal microscopy, optical coherence tomography and in skin biopsies.
oPhase 4 aims to assess efficacy of the device as a primary outcome and safety as a secondary outcome. This will be in subjects with type 1 diabetes over 5 days in ambulatory situation. Efficacy will be assessed by comparing microprobe sensor derived ISF glucose levels against ISF glucose levels measured using a commercially available CGM device (iPro2, Medtronic).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microprobe Glucose Sensor Phase 1 | Experimental | Device: Microprobe glucose sensorThe microprobe array continuous glucose sensor will be applied to healthy volunteers for 6 hours |
| Microprobe Glucose Sensor Phase 2 | Experimental | Device: Microprobe glucose sensorThe microprobe array continuous glucose sensor will be applied to healthy volunteers for 24 hours |
| Microprobe Glucose Sensor Phase 3 and 4 | Experimental | Device: Microprobe glucose sensorThe microprobe array continuous glucose sensor will be applied to participants with type 1 diabetes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over 18 years of age
- Adults over 18 years of age.
- Diagnosed with Type 1 diabetes for greater than 1 year.
- HbA1c less than or equal to 9.0 % (75 mmol/mol).
- Registered with a General Practitioner.
Key exclusion criteria (16 listed)
- History of upper limb neuropathy or radiculopathy
- History of pre-existing skin condition
- Pregnant or planning pregnancy in next 12 months
- Breastfeeding
- Enrolled in other clinical trials
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 |
|---|---|---|
| Microprobe glucose sensorAlso: Microprobe Array Continuous Glucose MonitorAssessment of safety and accuracy of a novel continuous glucose monitor based on microprobe technology. | Device | Microprobe Glucose Sensor Phase 1, Microprobe Glucose Sensor Phase 2, Microprobe Glucose Sensor Phase 3 and 4 |
Primary outcome
Number of Participant Developed the Skin Inflammation
Time frame: 24 hours
The study aims to assess safety of the use of microprobe array continuous glucose sensor with regards to skin inflammation.
Difference to the Venous Blood Glucose MARD
Time frame: 24 hours
Phase 3 of the study aim to assess efficacy of the device in people with type 1 diabetes. This will be done in comparison to venous blood glucose using YSI machine in a controlled environment over 24 hours (phase 3). it was originally planned to then compare this to ISF glucose in ambulatory situation over five days (phase 4) however phase 4 did not go ahead. Measured using mean absolute relative difference with respect to venous blood glucose
5 secondary outcomes
Pain Score
Time frame: 24 hours
Number of Participant Developed Skin Penetration
Time frame: 24 hours
Detectable Signal
Time frame: 24 hours
Correlation With Venous Blood Glucose
Time frame: 24 hours
Acceptability Questionnaire
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23234256El-Laboudi A, Oliver NS, Cass A, Johnston D. Use of microneedle array devices for continuous glucose monitoring: a review. Diabetes Technol Ther. 2013 Jan;15(1):101-15. doi: 10.1089/dia.2012.0188. Epub 2012 Dec 12.
- Background: PubMed 21737469Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
- Background: PubMed 21335621Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011 Apr;34(4):795-800. doi: 10.2337/dc10-1989. Epub 2011 Feb 19.
- Background: PubMed 19885301Khanna P, Strom JA, Malone JI, Bhansali S. Microneedle-based automated therapy for diabetes mellitus. J Diabetes Sci Technol. 2008 Nov;2(6):1122-9. doi: 10.1177/193229680800200621.
- Background: PubMed 18779236Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
- 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.
Desmond Johnston, PhD, FRCP principal investigator
Professor of Diabetes & Endocrinology - Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microprobe glucose sensor in people with Diabetes Mellitus, run by Imperial College London 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 20 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant Developed the Skin Inflammation (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908530, which also lists 5 linked publications.
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 20 Nov 2019.