N/A
Completed N=26
Clinical Assessment of a Novel Microprobe Array Continuous Glucose Monitor for Type 1 Diabetes
Source: ClinicalTrials.gov NCT01908530 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participant Developed the Skin Inflammation — 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Developed the Skin Inflammation |
0; 0; 0 | — |
| PRIMARY Difference to the Venous Blood Glucose MARD |
4 | — |
| SECONDARY Pain Score |
— | — |
| SECONDARY Number of Participant Developed Skin Penetration |
0; 0; 0 | — |
| SECONDARY Detectable Signal |
— | — |
| SECONDARY Correlation With Venous Blood Glucose |
— | — |
| SECONDARY Acceptability Questionnaire |
— | — |
Eligibility Criteria
For phases 1 and 2:
Inclusion Criteria
- Adults over 18 years of age
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01908530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.