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OpenTrials
Completed

NCT Number: NCT04731142

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammersmith & Fulham Central Primary Care Network, London, United Kingdom

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About this study

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 is being used in primary care to demonstrate how data and technology can improve health outcomes for people living with T2DM. The service has been designed via a cross-industry collaboration between North West London Clinical Commissioning Groups (NWL CCGs), AstraZeneca, Imperial College Health Partners and Huma. The service will be offered for patients at high risk of developing complications from T2DM (such as heart attack and stroke) and will combine video group consultations, remote monitoring via a smartphone app, and educational content such as lifestyle and diet advice.

This service seeks to strengthen population health management by providing better-tailored services and proactive interventions, particularly among population groups more at risk of the adverse impacts of COVID-19. Mortality risk from COVID-19 is approximately 25% higher in patients with T2DM and shielding has resulted in reduced primary care appointments for patients with T2DM. This has created an immediate need for primary care to adapt to provide care remotely to people with T2DM. Digital-first remote pathways could make care more accessible while finding time and cost efficiencies. By combining video group consultations and remote monitoring, we can inform the patient-clinician conversation making remote care in group settings safer, efficient and more personalised.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Huma

Device

Digital remote patient monitoring using blood pressure and blood sugar devices in combination with a smartphone app ('the Huma app'). Participants are provided with home monitoring devices and download the Huma app. Data recorded via the Huma app is self-reported and includes activity data, diet information, blood glucose measurements, blood pressure measurements, weight, and the Diabetes Distress Scale.

Other names: Huma app

Video group consultations

Behavioral

Each patient is invited to attend a total of three VGCs during the 12-weeks lasting approximately one hour and 15 minutes each. Each session is facilitated by a Practice Nurse (PN) and consists of 6-10 people with T2DM. The self-reported Huma app (see below) and patient EPR data are used to populate a "Discussion Dashboard" which is used in each VGC to facilitate discussion. During the first VGC session, patient goals are discussed and adjusted in a group setting with topics relevant to their condition covered by the PN. Between each VGC session, patients spend time working on their goals and continuing to enter self-reported metrics into the Huma app. During the second and third VGC sessions, each patient is discussed, along with their performance against agreed goals.

Other names: VGC

KNOW Diabetes

Behavioral

Each patient is signed up to a series of educational email campaigns to complement the VGC sessions and provide broader education around diabetes management. Patients receive two emails per week during the 12-week service on a variety of topics.

Standard of care

Other

Normal primary care service provided to matched control group.

Primary outcomes

  1. % Participants Downloading Huma App

    Time frame: 12 weeks

  2. Video Group Consultation Sessions Attended

    Time frame: 12 weeks

    the number of participants attending at least one VGC

  3. Blood Glucose Measurements Recorded

    Time frame: 12 weeks

    Number of participants entering at least one measurement

  4. Blood Pressure Measurements Recorded

    Time frame: 12 weeks

    Number of participants entering at least one blood pressure measurement

  5. Number of Weight Measurements Recorded

    Time frame: 12 weeks

    Number of participants entering at least one weight measurement

  6. Number of Diabetes Distress Scale Scores Recorded

    Time frame: 12 weeks

    Number of participants entering at least one DDS measurement

  7. Number of Deaths

    Time frame: 12 weeks

  8. Number of Participants With Emergency Department Admissions

    Time frame: 12 weeks

  9. Number of Participants With Hospital Admissions

    Time frame: 12 weeks

Secondary outcomes

  1. Change in HbA1c

    Time frame: 6 months

    Change in HbA1c from beginning to end of programme

  2. Change in Total Cholesterol

    Time frame: 6 months

    Change in total cholesterol from beginning to end of programme

  3. Change in Weight

    Time frame: 6 months

    Change in weight from beginning to end of programme

  4. Change in Systolic Blood Pressure

    Time frame: 6 months

    Change in systolic BP from beginning to end of programme

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • AstraZeneca
  • Huma
  • Imperial College Health Partners (ICHP)
  • North West London Collaboration of CCGs (NWL CCGs)

Registry information

Official study title

Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London

Acronym: T2DEx

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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