CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 235 enrolled
Drug / intervention
Huma +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04731142
NCT04731142N/ACompleted

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

Imperial College London·interventional·Posted Jan 29, 2021·Updated Feb 20, 2024

In Brief

A clinical study evaluating Huma, Video group consultations, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 235 participants across 7 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 29, 2021
Enrollment StartJun 1, 2021
Primary CompletionJun 30, 2022
Study CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.4 years ago

Interventions

Humadevice

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 consultationsbehavioral

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 Diabetesbehavioral

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.

Standard of careother

Normal primary care service provided to matched control group.