Type 2 Diabetes Exemplar: A Remote Care Service for North West London
NCT04731142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235
Last updated 2024-02-20
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
Interventions
- 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.
- 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.
- OTHER
-
Standard of care
Normal primary care service provided to matched control group.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Huma
collaborator INDUSTRY -
North West London Collaboration of CCGs (NWL CCGs)
collaborator OTHER -
Imperial College Health Partners (ICHP)
collaborator OTHER -
Imperial College London
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2022-06-30
- Completion
- 2022-10-31
Countries
- United Kingdom
Study Locations
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