Type 1 and Type 2 diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
There will be four sub-studies:
Sub-study A: Randomised feasibility study.
Sub-study B: Semi-structured interviews with patients on study acceptability and glycaemic target-setting.
Sub-study C: Semi-
Sponsors
St Helens and Knowsley Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Sub-study A: 1. Aged 18 and over. 2. Has Type 1 or Type 2 Diabetes. 3. HbA1c >/=64; </=125 mmol/mol. Sub-study B: 1. Enrolled in study A. Sub-study C: 1. Healthcare professional directly involved in the care of people with diabetes. Sub-study D: 1. Eligible patients declining entry into sub-study A will be approached for inclusion in study D.
Exclusion criteria
Exclusion criteria: Sub-study A: 1. Patients at risk of CVD events. 2. Patients with an episode of severe hypoglycaemia with the past 12 months. 3. Patients with hypoglycaemia unawareness (defined as a GOLD score =4). 4. Patients unwilling to self-monitor blood glucose at home (if clinical management requires). 5. Patients unwilling to inject insulin (if clinical management requires). 6. BMI =45 kg/m². 7. Patients who have opted-out from being contacted by researchers under the NHS national data opt-out service. 8. Patients with other serious illnesses which may limit survival or factors which may limit adherence to study interventions. 9. Patients currently participating in another clinical trial. 10. Patients with a transplanted organ. 11. Pregnancy. 12. Patients with requirements for regular blood transfusion or venesection. 13. Ongoing medical therapy known to cause difficulties with glycaemic control (e.g. corticosteroid therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub study A: 1. Eligibility rate recorded as number of screened patients who were eligible against inclusion/exclusion criteria per month. 2. Recruitment rate recorded as number of eligible patients who consented to participate in the study by 4 months. 3. First follow-up retention rate recorded as the number of participants who consent to participate and remain in the study until first follow-up at 3 months. 4. Last follow-up retention rate recorded as the number of participants who consent to participate and remain in the study until the final study visit at 6 months. 5. Response rate of the 3-month and 6-month psychometric questionnaires, recorded as the number of participants who consent to participate who fully complete the questionnaires pre- (3 months) and post-intervention (6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Sub-study A: 1. Health-related quality of life, measured using the EuroQoL 5D-5L (EQ-5D-5L) questionnaire, pre- (3 months post-randomisation) and post-intervention (6 months post-randomisation). 2. Diabetes-related distress, measured using the Problem Areas in Diabetes (PAID), pre- (3 months post-randomisation) and post-intervention (6 months post-randomisation). 3. Self-care in diabetes, measured using the Summary of Diabetes Self-care Activities (SDSCA), pre- (3 months post-randomisation) and post-intervention (6 months post-randomisation). 4. Wellbeing, measured using the Well Being Questionnaire-12 (WBQ-12), pre- (3 months post-randomisation) and post-intervention (6 months post-randomisation). 5. Diabetes empowerment, measured using the Diabetes Empowerment Scale-Long Form (DES-LF), pre- (3 months post-randomisation) and post-intervention (6 months post-randomisation). 6. Glycaemic control, measured using point-of-care glycated haemoglobin (HbA1c) at baseline, 3 months and 6 months. 7. Clinical outcomes such as height, weight and blood pressure at baseline, 3 months and 6 months. Sub-study B: 8. Semi-structured interviews with participants enrolled in sub-study A during the trial period at a convenient time for participants. Interviews will be transcribed and analysed using the framework method of content analysis. Sub-study C: 9. Semi-structured interviews with healthcare professionals during the trial period at a convenient time for participants. Interviews will be transcribed and analysed using the framework method of content analysis. Sub-study D: 10. Semi-structured interviews with patients who declined to enrol in sub-study A during the trial period at a convenient time for participants. Interviews will be transcribed and analysed using the framework method of content analysis. | — |
Countries
England, United Kingdom
Outcome results
None listed