Status:
COMPLETED
Clinical Assessment of a Novel Microprobe Array Continuous Glucose Monitor for Type 1 Diabetes
Lead Sponsor:
Imperial College London
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- For phases 1 and 2:
- • Adults over 18 years of age
Exclusion
- 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:
- Inclusion Criteria:
- 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.
- Exclusion criteria:
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01908530
Start Date
November 1 2013
End Date
June 1 2018
Last Update
November 20 2019
Active Locations (1)
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1
Imperial College London
London, United Kingdom, W2 1PG