search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Huma
Video group consultations
KNOW Diabetes
Standard of care
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Hammersmith & Fulham Central Primary Care Network
  • Hammersmith & Fulham Partnership Primary Care Network
  • Harrow Collaborative Primary Care Network
  • Healthsense Primary Care Network
  • Metrocare & Celandine Health Primary Crae Network
  • North Connect Primary Care Network
  • Sphere Primary Care Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

T2DEx remote care service

Matched control group

Arm Description

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'.

Outcomes

Primary Outcome Measures

Patients offered the service vs. enrolled
% participants downloading Huma app
% participants collecting remote monitoring devices
Number of video group consultation sessions attended
Number of KNOW Diabetes emails opened
Number of blood glucose measurements recorded
Number of blood pressure measurements recorded
Number of weight measurements recorded
Number of Diabetes Distress Scale scores recorded
Number of primary care appointments
Cost per appointment
Cost of equipment per patient
Number of deaths
Number of emergency department admissions
Number of hospital admissions

Secondary Outcome Measures

HbA1c
Lipids
Weight
Diabetes Distress Scale (DDS) Score
Blood glucose time-in-range
Systolic blood pressure

Full Information

First Posted
January 25, 2021
Last Updated
January 20, 2023
Sponsor
Imperial College London
Collaborators
AstraZeneca, Huma, North West London Collaboration of CCGs (NWL CCGs), Imperial College Health Partners (ICHP)
search

1. Study Identification

Unique Protocol Identification Number
NCT04731142
Brief Title
Type 2 Diabetes Exemplar: A Remote Care Service for North West London
Acronym
T2DEx
Official Title
Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
AstraZeneca, Huma, North West London Collaboration of CCGs (NWL CCGs), Imperial College Health Partners (ICHP)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An experimental feasibility study with a pre-test/post-test design using a matched control.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T2DEx remote care service
Arm Type
Experimental
Arm Title
Matched control group
Arm Type
Other
Arm Description
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'.
Intervention Type
Device
Intervention Name(s)
Huma
Other Intervention Name(s)
Huma app
Intervention Description
V. Digital remote patient monitoring using blood pressure and blood sugar devices in combination with a smartphone application ('the Huma app'). Participants are provided with home monitoring devices and download the Huma app. Participants are shown how to use the devices, how to input measurements into a smart phone and how to set personal goals. 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 (a self-reported questionnaire used to measure distress related to living with diabetes).
Intervention Type
Behavioral
Intervention Name(s)
Video group consultations
Other Intervention Name(s)
VGC
Intervention Description
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. The PN also uses pre-prepared content to discuss topics relevant to managing diabetes (e.g., staying motivated, low carb diets).
Intervention Type
Behavioral
Intervention Name(s)
KNOW Diabetes
Intervention Description
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
Other
Intervention Name(s)
Standard of care
Intervention Description
Normal primary care service provided to matched control group.
Primary Outcome Measure Information:
Title
Patients offered the service vs. enrolled
Time Frame
12 weeks
Title
% participants downloading Huma app
Time Frame
12 weeks
Title
% participants collecting remote monitoring devices
Time Frame
12 weeks
Title
Number of video group consultation sessions attended
Time Frame
12 weeks
Title
Number of KNOW Diabetes emails opened
Time Frame
12 weeks
Title
Number of blood glucose measurements recorded
Time Frame
12 weeks
Title
Number of blood pressure measurements recorded
Time Frame
12 weeks
Title
Number of weight measurements recorded
Time Frame
12 weeks
Title
Number of Diabetes Distress Scale scores recorded
Time Frame
12 weeks
Title
Number of primary care appointments
Time Frame
12 weeks
Title
Cost per appointment
Time Frame
12 weeks
Title
Cost of equipment per patient
Time Frame
12 weeks
Title
Number of deaths
Time Frame
12 weeks
Title
Number of emergency department admissions
Time Frame
12 weeks
Title
Number of hospital admissions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
6 months
Title
Lipids
Time Frame
6 months
Title
Weight
Time Frame
6 months
Title
Diabetes Distress Scale (DDS) Score
Time Frame
6 months
Title
Blood glucose time-in-range
Time Frame
6 months
Title
Systolic blood pressure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Hammersmith & Fulham Central Primary Care Network
City
London
Country
United Kingdom
Facility Name
Hammersmith & Fulham Partnership Primary Care Network
City
London
Country
United Kingdom
Facility Name
Harrow Collaborative Primary Care Network
City
London
Country
United Kingdom
Facility Name
Healthsense Primary Care Network
City
London
Country
United Kingdom
Facility Name
Metrocare & Celandine Health Primary Crae Network
City
London
Country
United Kingdom
Facility Name
North Connect Primary Care Network
City
London
Country
United Kingdom
Facility Name
Sphere Primary Care Network
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs