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

NCT04731142 | Completed Results

• 1 other identifier: 20IC6484
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 7

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 complications from Type 2 Diabetes Mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (9)

• % Participants Downloading Huma App

  12 weeks

• Video Group Consultation Sessions Attended

  the number of participants attending at least one VGC

  12 weeks

• Blood Glucose Measurements Recorded

  Number of participants entering at least one measurement

  12 weeks

• Blood Pressure Measurements Recorded

  Number of participants entering at least one blood pressure measurement

  12 weeks

• Number of Weight Measurements Recorded

  Number of participants entering at least one weight measurement

  12 weeks

• Number of Diabetes Distress Scale Scores Recorded

  Number of participants entering at least one DDS measurement

  12 weeks

• Number of Deaths

  12 weeks

• Number of Participants With Emergency Department Admissions

  12 weeks

• Number of Participants With Hospital Admissions

  12 weeks

Secondary Outcomes (4)

• Change in HbA1c

  6 months

• Change in Total Cholesterol

  6 months

• Change in Weight

  6 months

• Change in Systolic Blood Pressure

  6 months

Study Arms (2)

T2DEx remote care service

EXPERIMENTAL

Device: Huma; Behavioral: Video group consultations; Behavioral: KNOW Diabetes

Matched control group

OTHER

This study will create a matched control group using propensity score matching (PSM), a quasi-experimental method used to mimic the characteristics of a randomised control trial that has been shown to reduce biases. PSM uses statistical techniques to construct an artificial control group by matching each study participant with a non-treated participant of similar characteristics. PSM computes the probability that a person would enrol in a program based on pre-defined characteristics, giving a 'propensity score'.

Other: Standard of care

Interventions

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.

Also known as: Huma app

T2DEx remote care service

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.

Also known as: VGC

T2DEx remote care service

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.

T2DEx remote care service

Standard of care OTHER

Normal primary care service provided to matched control group.

Matched control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (7)

Hammersmith & Fulham Central Primary Care Network

London, United Kingdom

Location

Hammersmith & Fulham Partnership Primary Care Network

London, United Kingdom

Location

Harrow Collaborative Primary Care Network

London, United Kingdom

Location

Healthsense Primary Care Network

London, United Kingdom

Location

Metrocare & Celandine Health Primary Crae Network

London, United Kingdom

Location

North Connect Primary Care Network

London, United Kingdom

Location

Sphere Primary Care Network

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr Jack Halligan
• Organization: Imperial College London

j.halligan@imperial.ac.uk

+447742161980

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An experimental feasibility study with a pre-test/post-test design using a matched control.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: October 31, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)