Status:
COMPLETED
Type 2 Diabetes Exemplar: A Remote Care Service for North West London
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
AstraZeneca
Huma
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of T2DEx is to assess the feasibility, usability, acceptability, cost-effectiveness and safety of a digital support service for people in North West London at high risk of developing complicat...
Detailed Description
The Type 2 Diabetes Exemplar Programme has been designed as a collaborative effort through partners from the Discover-NOW Health Data Research Hub in North West London (NWL). The remote care service i...
Eligibility Criteria
Inclusion
- Patients over the age of 18 with the capacity to give consent
- Patients with 'high risk' OR 'very high risk' T2DM as defined by:
- Very high risk - T2DM with existing ASCVD OR T2DM without ASCVD but with any 3 of the following:
- HbA1c \>58
- SBP \>140
- Non-HDL \>3.35 or LDL-C \>2.5
- Nephropathy (eGFR \<45, or Urine ACR \>3)
- Retinopathy
- Neuropathy (including moderate/high risk feet, previous foot ulceration and erectile dysfunction)
- Currently smoking
- High risk - T2DM without ASCVD but with any 2 of the following:
- HbA1c \> 58
- SBP \>140
- Non-HDL \>3.35 or LDL-C \>2.5
- Nephropathy: eGFR \<45 or Urine ACR \>3
- Retinopathy
- Neuropathy (including moderate/high risk feet, previous foot ulceration and erectile dysfunction)
- Currently smoking
- Black, Asian and minority ethic (BAME) status
Exclusion
- Participants too ill to participate in the study (i.e., presence of a life-threatening condition, expected survival less than 3 months, clinically unstable)
- Participants who have previously participated in efforts that have informed the design of this research.
- Participant without access to a smartphone.
- Non-English language (the remote monitoring technology currently does not support additional languages).
- Visual disability (the remote monitoring technology currently does not natively support visual assistance).
- Active severe mental illness (SMI).
- Alcohol / drug abuse.
- Severe frailty (identified via the Electronic Frailty Index - eFI).
- Housebound / living in nursing home.
- Currently on the REWIND Programme (a NWL total diet replacement programme for patients with type-2 diabetes).
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT04731142
Start Date
June 1 2021
End Date
October 31 2022
Last Update
February 20 2024
Active Locations (7)
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1
Hammersmith & Fulham Central Primary Care Network
London, United Kingdom
2
Hammersmith & Fulham Partnership Primary Care Network
London, United Kingdom
3
Harrow Collaborative Primary Care Network
London, United Kingdom
4
Healthsense Primary Care Network
London, United Kingdom