N/A
N=235
Type 2 Diabetes Exemplar: A Remote Care Service for North West London
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04731142 ↗Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: % Participants Downloading Huma App — 95; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Huma (Device); Video group consultations (Behavioral); KNOW Diabetes (Behavioral); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Participants Downloading Huma App |
95; 0 | — |
| PRIMARY Video Group Consultation Sessions Attended |
78; 0 | — |
| PRIMARY Blood Glucose Measurements Recorded |
82; 0 | — |
| PRIMARY Blood Pressure Measurements Recorded |
90; 0 | — |
| PRIMARY Number of Weight Measurements Recorded |
88; 0 | — |
| PRIMARY Number of Diabetes Distress Scale Scores Recorded |
45; 0 | — |
| PRIMARY Number of Deaths |
0; 0 | — |
| PRIMARY Number of Participants With Emergency Department Admissions |
10; 14 | — |
| PRIMARY Number of Participants With Hospital Admissions |
57; 42 | — |
| SECONDARY Change in HbA1c |
-3.7; -1.72 | — |
| SECONDARY Change in Total Cholesterol |
0.425; -0.0182 | — |
| SECONDARY Change in Weight |
-2.17; -1.6 | — |
| SECONDARY Change in Systolic Blood Pressure |
-3.35; -4.86 | — |
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).
Eligibility Criteria
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 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 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).
Data sourced from ClinicalTrials.gov (NCT04731142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.