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Type 2 Diabetes Exemplar: A Remote Care Service for North West London
Type 2 Diabetes Exemplar: A Remote Care Service for North West London

NCT04731142

CompletedNA

Sponsor: Imperial College London

Conditions: Type 2 Diabetes Mellitus

Interventions: Huma, Video group consultations, KNOW Diabetes, Standard of care

Countries: United Kingdom

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 complications from Type 2 Diabetes Mellitus (T2DM).

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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).
Locations (7)
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom