Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DEVICEHuma
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.
BEHAVIORALVideo 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.
BEHAVIORALKNOW 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.
OTHERStandard of care
Normal primary care service provided to matched control group.
Sponsors
AstraZeneca
Huma
North West London Collaboration of CCGs (NWL CCGs)
Imperial College Health Partners (ICHP)
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An experimental feasibility study with a pre-test/post-test design using a matched control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Admissions | 12 weeks | — |
| Number of Weight Measurements Recorded | 12 weeks | Number of participants entering at least one weight measurement |
| Number of Diabetes Distress Scale Scores Recorded | 12 weeks | Number of participants entering at least one DDS measurement |
| Number of Deaths | 12 weeks | — |
| Number of Participants With Emergency Department Admissions | 12 weeks | — |
| % Participants Downloading Huma App | 12 weeks | — |
| Video Group Consultation Sessions Attended | 12 weeks | the number of participants attending at least one VGC |
| Blood Glucose Measurements Recorded | 12 weeks | Number of participants entering at least one measurement |
| Blood Pressure Measurements Recorded | 12 weeks | Number of participants entering at least one blood pressure measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol | 6 months | Change in total cholesterol from beginning to end of programme |
| Change in Weight | 6 months | Change in weight from beginning to end of programme |
| Change in Systolic Blood Pressure | 6 months | Change in systolic BP from beginning to end of programme |
| Change in HbA1c | 6 months | Change in HbA1c from beginning to end of programme |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 118 |
| 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. | 117 |
| Total | 235 |
Baseline characteristics
| Characteristic | T2DEx Remote Care Service | Matched Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 118 Participants | 117 Participants | 235 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 117 Participants | 235 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 118 participants | 117 participants | 235 participants |
| Sex: Female, Male Female | 69 Participants | 75 Participants | 144 Participants |
| Sex: Female, Male Male | 49 Participants | 42 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 117 |
| other Total, other adverse events | 0 / 118 | 0 / 117 |
| serious Total, serious adverse events | 0 / 118 | 0 / 117 |
Outcome results
Primary
Blood Glucose Measurements Recorded
Number of participants entering at least one measurement
Time frame: 12 weeks
Population: Patients in the matched control group did not have access to remote monitoring devices
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Blood Glucose Measurements Recorded | 82 Participants |
| Matched Control Group | Blood Glucose Measurements Recorded | 0 Participants |
Primary
Blood Pressure Measurements Recorded
Number of participants entering at least one blood pressure measurement
Time frame: 12 weeks
Population: Patients in the matched control group did not have access to remote monitoring devices
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Blood Pressure Measurements Recorded | 90 Participants |
| Matched Control Group | Blood Pressure Measurements Recorded | 0 Participants |
Primary
Number of Deaths
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Number of Deaths | 0 Participants |
| Matched Control Group | Number of Deaths | 0 Participants |
Primary
Number of Diabetes Distress Scale Scores Recorded
Number of participants entering at least one DDS measurement
Time frame: 12 weeks
Population: Patients in the matched control group did not have access to the Huma app to complete the DDS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Number of Diabetes Distress Scale Scores Recorded | 45 Participants |
| Matched Control Group | Number of Diabetes Distress Scale Scores Recorded | 0 Participants |
Primary
Number of Participants With Emergency Department Admissions
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Number of Participants With Emergency Department Admissions | 10 Participants |
| Matched Control Group | Number of Participants With Emergency Department Admissions | 14 Participants |
Primary
Number of Participants With Hospital Admissions
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Number of Participants With Hospital Admissions | 57 Participants |
| Matched Control Group | Number of Participants With Hospital Admissions | 42 Participants |
Primary
Number of Weight Measurements Recorded
Number of participants entering at least one weight measurement
Time frame: 12 weeks
Population: Patients in the matched control group did not have access to remote monitoring devices
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Number of Weight Measurements Recorded | 88 Participants |
| Matched Control Group | Number of Weight Measurements Recorded | 0 Participants |
Primary
% Participants Downloading Huma App
Time frame: 12 weeks
Population: Participants in matched control group did not have access the Huma app
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | % Participants Downloading Huma App | 95 Participants |
| Matched Control Group | % Participants Downloading Huma App | 0 Participants |
Primary
Video Group Consultation Sessions Attended
the number of participants attending at least one VGC
Time frame: 12 weeks
Population: Participants in the matched control group were not provided with VGCs
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T2DEx Remote Care Service | Video Group Consultation Sessions Attended | 78 Participants |
| Matched Control Group | Video Group Consultation Sessions Attended | 0 Participants |
Secondary
Change in HbA1c
Change in HbA1c from beginning to end of programme
Time frame: 6 months
Population: HbA1c tests not taken from all participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| T2DEx Remote Care Service | Change in HbA1c | -3.7 mg/dL |
| Matched Control Group | Change in HbA1c | -1.72 mg/dL |
Secondary
Change in Systolic Blood Pressure
Change in systolic BP from beginning to end of programme
Time frame: 6 months
Population: Systolic BP tests not taken from all participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| T2DEx Remote Care Service | Change in Systolic Blood Pressure | -3.35 mmHg |
| Matched Control Group | Change in Systolic Blood Pressure | -4.86 mmHg |
Secondary
Change in Total Cholesterol
Change in total cholesterol from beginning to end of programme
Time frame: 6 months
Population: Cholesterol tests not taken from all participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| T2DEx Remote Care Service | Change in Total Cholesterol | 0.425 mg/dL |
| Matched Control Group | Change in Total Cholesterol | -0.0182 mg/dL |
Secondary
Change in Weight
Change in weight from beginning to end of programme
Time frame: 6 months
Population: Weight not entered by all participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| T2DEx Remote Care Service | Change in Weight | -2.17 kg |
| Matched Control Group | Change in Weight | -1.6 kg |