Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
A. Design
This will be a prospective cohort study. The effectiveness of interventions will be assessed within patients by comparing before and after intervention levels of risk factors such as glucose
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the main intervention (DMW): 1. Age > = 18 years 2. T2D (as determined by primary or secondary care records) 3. Registered with GP in GM or other diabetes care provider e.g. hospital is linked to DMW 4. Self-certified understanding of spoken and written English or available support from family or friends 5. Able to access a digital device Additional selection criteria for participants/practices offered other digital interventions: MDMW will apply additional selection criteria (described under a-d below) prior to patients being offered access to targeted digital interventions. Once offered, participants will be encouraged to discuss the option of their participation with these targeted digital interventions with their regular clinical team members responsible for their diabetes care. The final decision to participate in these targeted digital interventions will rest with the patient. 1. Behavioural interventions (Oviva or Changing Health) will each be offered to 600 participants. The researchers will exclude people self-reporting current pregnancy, those treated with insulin (Changing Health only), those with no contraindication for weight loss or physical activity (Changing Health only) and those receiving diabetes care at a location other than their GP surgery. 2. MyCognition assessment will be offered to all DMW participants and the MyCognition intervention will be offered to the first 1000 participants who complete the assessment (as explained above). There will be no additional selection criteria. 3. Billaway: This intervention will be offered to up to 600 patients in the lowest quartile for diabetes clinic attendance rates. When the researchers have access to attendance rate data then this, for example, might mean offering the intervention to people who had failed to attend their previous two diabetes clinic appointments. The researchers will focus primarily, but not exclusively, on research-active practices currently supported by the Diabetes Clinical Research Network. The researchers will not invite those receiving diabetes care somewhere other than the GP surgery.
Exclusion criteria
Exclusion criteria: 1. Age < 18 years 2. No T2D (as determined by primary or secondary care records) 3. Not registered with GP in GM 4. Unable to understand spoken and written English 5. Unable to access a digital device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Average within-person changes in HbA1c in participants using Diabetes My Way (measured by either immunoassay, ion-exchange high-performance liquid chromatography, boronate affinity HPLC, or enzymatic assays in an accredited NHS biochemistry lab) at some time prior to enrolment and after 3-6 months as clinically indicated 2. Average within-person change in HbA1c in participants using the behavioural interventions (Oviva and Changing Health) (measured by either immunoassay, ion-exchange high-performance liquid chromatography, boronate affinity HPLC, or enzymatic assays in an accredited NHS biochemistry lab) at some time prior to enrolment and after 3-6 months as clinically indicated 3. Average within-person changes in diabetes distress scores in participants using MyCognition as assessed by online questionnaire (www.diabetesed.net/page/_files/diabetes-distress.pdf) prior to intervention and after 3 to 6 months 4. Within-person changes in attendance rate and estimate associated costs in participants using BillawayHealth; attendance rates assessed from practice records comparing before and after the intervention, which may last from when the study starts until October 2020 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Average within-person changes in systolic blood pressure, cholesterol, smoking and bodyweight/BMI in participants using Diabetes My Way: 1.1. Blood pressure measured by sphygmomanometer 1.2. Cholesterol measured using conventional methods in an accredited NHS biochemistry lab 1.3. Smoking assessed from data collected from the primary care record 1.4. Bodyweight assessed using calibrated scales in primary care 1.5. BMI assessed from weight in kilograms divided by height squared (in metres) 2. Average within-person changes in systolic blood pressure, cholesterol, smoking and bodyweight/BMI in participants using the behavioural interventions (Oviva and Changing Health): 2.1. Blood pressure measured by sphygmomanometer 2.2. Cholesterol measured using conventional methods in an accredited NHS biochemistry lab 2.3. Smoking assessed from data collected from the primary care record 2.4. Bodyweight assessed using calibrated scales in primary care 2.5. BMI assessed from weight in kilograms divided by height squared (in metres) All secondary outcomes assessed in primary care sometime prior to enrolment and after 3 to 6 months as clinically indicated | — |
Countries
England, United Kingdom
Contacts
Public ContactEwan Jones
Outcome results
None listed