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

Type 2 Diabetes Mellitus Clinical Trial

— T2DEx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731142
• Other study ID #: 20IC6484
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 complications from Type 2 Diabetes Mellitus (T2DM).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Huma
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.

Behavioral:
• Video group consultations
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.
• KNOW Diabetes
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.

Other:
• Standard of care
Normal primary care service provided to matched control group.

Locations

Country	Name	City	State
United Kingdom	Hammersmith & Fulham Central Primary Care Network	London
United Kingdom	Hammersmith & Fulham Partnership Primary Care Network	London
United Kingdom	Harrow Collaborative Primary Care Network	London
United Kingdom	Healthsense Primary Care Network	London
United Kingdom	Metrocare & Celandine Health Primary Crae Network	London
United Kingdom	North Connect Primary Care Network	London
United Kingdom	Sphere Primary Care Network	London

Sponsors (5)

Lead Sponsor	Collaborator
Imperial College London	AstraZeneca, Huma, Imperial College Health Partners (ICHP), North West London Collaboration of CCGs (NWL CCGs)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Participants Downloading Huma App		12 weeks
Primary	Video Group Consultation Sessions Attended	the number of participants attending at least one VGC	12 weeks
Primary	Blood Glucose Measurements Recorded	Number of participants entering at least one measurement	12 weeks
Primary	Blood Pressure Measurements Recorded	Number of participants entering at least one blood pressure measurement	12 weeks
Primary	Number of Weight Measurements Recorded	Number of participants entering at least one weight measurement	12 weeks
Primary	Number of Diabetes Distress Scale Scores Recorded	Number of participants entering at least one DDS measurement	12 weeks
Primary	Number of Deaths		12 weeks
Primary	Number of Participants With Emergency Department Admissions		12 weeks
Primary	Number of Participants With Hospital Admissions		12 weeks
Secondary	Change in HbA1c	Change in HbA1c from beginning to end of programme	6 months
Secondary	Change in Total Cholesterol	Change in total cholesterol from beginning to end of programme	6 months
Secondary	Change in Weight	Change in weight from beginning to end of programme	6 months
Secondary	Change in Systolic Blood Pressure	Change in systolic BP from beginning to end of programme	6 months