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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T2DEx remote care service

Group Type EXPERIMENTAL

Huma

Intervention Type 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.

Video group consultations

Intervention Type 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.

KNOW Diabetes

Intervention Type 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.

Matched control group

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'.

Group Type OTHER

Standard of care

Intervention Type OTHER

Normal primary care service provided to matched control group.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Standard of care

Normal primary care service provided to matched control group.

Intervention Type OTHER

Other Intervention Names

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Huma app VGC

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes