NCT01908530

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 20, 2019

Completed
Last Updated

November 20, 2019

Status Verified

October 1, 2019

Enrollment Period

3.6 years

First QC Date

July 23, 2013

Results QC Date

June 24, 2019

Last Update Submit

October 31, 2019

Conditions

Diabetes Mellitus

Keywords

DiabetesContinuous Glucose MonitoringMicroprobes

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    24 hours

Secondary Outcomes (5)

  • Pain Score

    24 hours

  • Number of Participant Developed Skin Penetration

    24 hours

  • Detectable Signal

    24 hours

  • Correlation With Venous Blood Glucose

    24 hours

  • Acceptability Questionnaire

    24 hours

Study Arms (3)

Microprobe Glucose Sensor Phase 1

EXPERIMENTAL

The microprobe array continuous glucose sensor will be applied to healthy volunteers for 6 hours

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

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

Device: Microprobe glucose sensor

Interventions

Microprobe glucose sensorDEVICE

Assessment of safety and accuracy of a novel continuous glucose monitor based on microprobe technology.

Also known as: Microprobe Array Continuous Glucose Monitor
Microprobe Glucose Sensor Phase 1Microprobe Glucose Sensor Phase 2Microprobe Glucose Sensor Phase 3 and 4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 18 years of age

You may not qualify if:

  • 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
  • Have active malignancy or under investigation for malignancy
  • For phases 3 and 4:
  • 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.
  • History of diabetic dermopathy or pre-existing skin condition
  • History of upper limb neuropathy or radiculopathy
  • Pregnant or planning pregnancy in next 12 months
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, W2 1PG, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 23234256BACKGROUND

  • Pickup 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.

    PMID: 21737469BACKGROUND

  • Battelino 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.

    PMID: 21335621BACKGROUND

  • Khanna 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.

    PMID: 19885301BACKGROUND

  • Juvenile 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.

    PMID: 18779236BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Prof Nick Oliver
Organization
Imperial College London
nick.oliver@imperial.ac.uk
07957163617

Study Officials

  • Desmond Johnston, PhD, FRCP

    Professor of Diabetes & Endocrinology - Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

November 20, 2019

Results First Posted

November 20, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)