Status:
COMPLETED
Closed-loop in Adults With T2D Requiring Dialysis
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
Conditions:
Type 2 Diabetes
End Stage Renal Disease
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 a 20 day period in adults with type 2 diabetes...
Detailed Description
Purpose of clinical trial To determine the efficacy, safety and utility of fully automated closed-loop insulin delivery in the home setting in adults with type 2 diabetes requiring maintenance dialysi...
Eligibility Criteria
Inclusion
- The subject is age 18 years or over
- Diagnosis of type 2 diabetes using standard diagnostic practice
- The subject requires maintenance dialysis
- The subject requires 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
- The subject is literate in English (UK) or German (Switzerland)
- The subject is willing to wear study devices 24/7 during intervention arm and follow study specific instructions
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 or unable to tolerate tape adhesive in the area of sensor placement
- 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 :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04025775
Start Date
August 1 2019
End Date
March 1 2021
Last Update
May 17 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Inselspital, Bern University Hospital
Bern, Switzerland
2
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ