Status:
COMPLETED
Closed-loop in Adults With T2D Not Requiring Dialysis
Lead Sponsor:
University of Cambridge
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over an 8 week period in adults with type 2 diabete...
Eligibility Criteria
Inclusion
- Age 18 years or over
- Diagnosis of type 2 diabetes using standard diagnostic practice
- Current treatment with subcutaneous insulin
- Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- Subject is willing to perform regular finger-prick blood glucose monitoring
- Willingness to wear study devices
- Literate in English
Exclusion
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Known or suspected allergy to insulin
- Lack of reliable telephone facility for contact
- Pregnancy, planned pregnancy, or breast feeding
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- Illicit drugs abuse
- Prescription drugs abuse
- Alcohol abuse
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04701424
Start Date
December 16 2020
End Date
March 30 2022
Last Update
May 31 2022
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ