Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Huma | INDUSTRY |
| North West London Collaboration of CCGs (NWL CCGs) | OTHER |
| Imperial College Health Partners (ICHP) |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DEx remote care service | Experimental |
| |
| 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'. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huma | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| % Participants Downloading Huma App | 12 weeks | |
| Video Group Consultation Sessions Attended | the number of participants attending at least one VGC | 12 weeks |
| Blood Glucose Measurements Recorded | Number of participants entering at least one measurement | 12 weeks |
| Blood Pressure Measurements Recorded | Number of participants entering at least one blood pressure measurement | 12 weeks |
| Number of Weight Measurements Recorded | Number of participants entering at least one weight measurement | 12 weeks |
| Number of Diabetes Distress Scale Scores Recorded | Number of participants entering at least one DDS measurement | 12 weeks |
| Number of Deaths | 12 weeks | |
| Number of Participants With Emergency Department Admissions | 12 weeks | |
| Number of Participants With Hospital Admissions | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from beginning to end of programme | 6 months |
| Change in Total Cholesterol | Change in total cholesterol from beginning to end of programme |
Not provided
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:
High risk - T2DM without ASCVD but with any 2 of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith & Fulham Central Primary Care Network | London | United Kingdom | ||||
| Hammersmith & Fulham Partnership Primary Care Network |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment started in June 2021 and primary completion date was 30 June 2022. Patients were recruited from 5 primary care networks (PCNs) in North West London.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | T2DEx Remote Care Service | 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. 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. 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. |
| FG001 | 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'. Standard of care: Normal primary care service provided to matched control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T2DEx Remote Care Service | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Participants Downloading Huma App | Participants in matched control group did not have access the Huma app | Posted | Count of Participants | Participants | 12 weeks |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T2DEx Remote Care Service | 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. 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jack Halligan | Imperial College London | +447742161980 | j.halligan@imperial.ac.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2021 | Jun 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2022 | Jun 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| OTHER |
An experimental feasibility study with a pre-test/post-test design using a matched control.
Not provided
Not provided
Not provided
Not provided
|
|
| Video group consultations | 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 | 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. |
|
| Standard of care | Other | Normal primary care service provided to matched control group. |
|
| 6 months |
| Change in Weight | Change in weight from beginning to end of programme | 6 months |
| Change in Systolic Blood Pressure | Change in systolic BP from beginning to end of programme | 6 months |
| London |
| United Kingdom |
| Harrow Collaborative Primary Care Network | London | United Kingdom |
| Healthsense Primary Care Network | London | United Kingdom |
| Metrocare & Celandine Health Primary Crae Network | London | United Kingdom |
| North Connect Primary Care Network | London | United Kingdom |
| Sphere Primary Care Network | London | United Kingdom |
| BG001 | 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'. Standard of care: Normal primary care service provided to matched control group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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'. Standard of care: Normal primary care service provided to matched control group. |
|
|
| Primary | Video Group Consultation Sessions Attended | the number of participants attending at least one VGC | Participants in the matched control group were not provided with VGCs | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Blood Glucose Measurements Recorded | Number of participants entering at least one measurement | Patients in the matched control group did not have access to remote monitoring devices | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Blood Pressure Measurements Recorded | Number of participants entering at least one blood pressure measurement | Patients in the matched control group did not have access to remote monitoring devices | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Number of Weight Measurements Recorded | Number of participants entering at least one weight measurement | Patients in the matched control group did not have access to remote monitoring devices | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Number of Diabetes Distress Scale Scores Recorded | Number of participants entering at least one DDS measurement | Patients in the matched control group did not have access to the Huma app to complete the DDS | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Number of Deaths | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Number of Participants With Emergency Department Admissions | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Number of Participants With Hospital Admissions | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Change in HbA1c | Change in HbA1c from beginning to end of programme | HbA1c tests not taken from all participants | Posted | Mean | 95% Confidence Interval | mg/dL | 6 months |
|
|
|
| Secondary | Change in Total Cholesterol | Change in total cholesterol from beginning to end of programme | Cholesterol tests not taken from all participants | Posted | Mean | 95% Confidence Interval | mg/dL | 6 months |
|
|
|
| Secondary | Change in Weight | Change in weight from beginning to end of programme | Weight not entered by all participants | Posted | Mean | 95% Confidence Interval | kg | 6 months |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Change in systolic BP from beginning to end of programme | Systolic BP tests not taken from all participants | Posted | Mean | 95% Confidence Interval | mmHg | 6 months |
|
|
|
| 0 |
| 118 |
| 0 |
| 118 |
| 0 |
| 118 |
| EG001 | 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'. Standard of care: Normal primary care service provided to matched control group. | 0 | 117 | 0 | 117 | 0 | 117 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |