Type 2 Diabetes MellitusT2DExNCT04731142
Type 2 Diabetes Exemplar: A Remote Care Service for North West London
A study testing Huma, Video group consultations and KNOW Diabetes in people with Type 2 Diabetes Mellitus, run by Imperial College London at 7 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Huma, Video group consultations and KNOW Diabetes
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 1 Jun 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Hammersmith & Fulham Central Primary Care Network
London
Hammersmith & Fulham Partnership Primary Care Network
London
Harrow Collaborative Primary Care Network
London
Healthsense Primary Care Network
London
Metrocare & Celandine Health Primary Crae Network
London
North Connect Primary Care Network
London
Sphere Primary Care Network
London
About this study
Official title: Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
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).
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Huma, Video group consultations, KNOW Diabetes, Standard of care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumaDevice
Also called Huma app
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 consultationsBehavioural
Also called VGC
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 DiabetesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| T2DEx remote care service | Experimental | Not described Receives: 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'. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Participants Downloading Huma App
Measured: 12 weeks
Video Group Consultation Sessions Attended
the number of participants attending at least one VGC
Measured: 12 weeks
Blood Glucose Measurements Recorded
Number of participants entering at least one measurement
Measured: 12 weeks
Blood Pressure Measurements Recorded
Number of participants entering at least one blood pressure measurement
Measured: 12 weeks
Number of Weight Measurements Recorded
Number of participants entering at least one weight measurement
Measured: 12 weeks
Number of Diabetes Distress Scale Scores Recorded
Number of participants entering at least one DDS measurement
Measured: 12 weeks
Number of Deaths
Measured: 12 weeks
Number of Participants With Emergency Department Admissions
Measured: 12 weeks
Number of Participants With Hospital Admissions
Measured: 12 weeks
Secondary outcomes (4)
Change in HbA1c
Change in HbA1c from beginning to end of programme
Measured: 6 months
Change in Total Cholesterol
Change in total cholesterol from beginning to end of programme
Measured: 6 months
Change in Weight
Change in weight from beginning to end of programme
Measured: 6 months
Change in Systolic Blood Pressure
Change in systolic BP from beginning to end of programme
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An experimental feasibility study with a pre-test/post-test design using a matched control.
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Huma, North West London Collaboration of CCGs (NWL CCGs), Imperial College Health Partners (ICHP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731142
- Sponsor's protocol ID
- 20IC6484
- Acronym
- T2DEx
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2021
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
- ClinicalTrials.gov ID
- NCT04731142
- Acronym / sponsor ID
- T2DEx / 20IC6484
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- AstraZeneca, Huma, North West London Collaboration of CCGs (NWL CCGs), Imperial College Health Partners (ICHP)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An experimental feasibility study with a pre-test/post-test design using a matched control.
| Arm | Type | Receives |
|---|---|---|
| T2DEx remote care service | Experimental | Device: Huma, Behavioral: Video group consultations, Behavioral: KNOW Diabetes |
| Matched control group | Other | Other: Standard of careThis 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'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients over the age of 18 with the capacity to give consent
- Patients with 'high risk' OR 'very high risk' T2DM as defined by:
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumaAlso: Huma appDigital 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. | Device | T2DEx remote care service |
| Video group consultationsAlso: VGCEach 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. | Behavioural | T2DEx remote care service |
| KNOW DiabetesEach 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. | Behavioural | T2DEx remote care service |
| Standard of careNormal primary care service provided to matched control group. | Other | Matched control group |
Primary outcome
% Participants Downloading Huma App
Time frame: 12 weeks
Video Group Consultation Sessions Attended
Time frame: 12 weeks
the number of participants attending at least one VGC
Blood Glucose Measurements Recorded
Time frame: 12 weeks
Number of participants entering at least one measurement
Blood Pressure Measurements Recorded
Time frame: 12 weeks
Number of participants entering at least one blood pressure measurement
Number of Weight Measurements Recorded
Time frame: 12 weeks
Number of participants entering at least one weight measurement
Number of Diabetes Distress Scale Scores Recorded
Time frame: 12 weeks
Number of participants entering at least one DDS measurement
Number of Deaths
Time frame: 12 weeks
Number of Participants With Emergency Department Admissions
Time frame: 12 weeks
Number of Participants With Hospital Admissions
Time frame: 12 weeks
4 secondary outcomes
Change in HbA1c
Time frame: 6 months
Change in Total Cholesterol
Time frame: 6 months
Change in Weight
Time frame: 6 months
Change in Systolic Blood Pressure
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huma, Video group consultations and KNOW Diabetes in people with Type 2 Diabetes Mellitus, run by Imperial College London at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Participants Downloading Huma App (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.