Wellbeing outcomes of blood sugar control (HbA1c) target-setting in diabetes

Not Applicable

Completed

• Conditions: Type 1 and Type 2 diabetes; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN12461724
• Lead Sponsor: St Helens and Knowsley Teaching Hospitals NHS Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36302049/ (added 28/10/2022) 2023 Abstract results in https://doi.org/10.1111/dme.15048 Abstracts P300, P302 and P303. Presented at the Diabetes UK Professional Conference 2023. (added 04/08/2023) 2023 Abstract results in https://doi.org/10.2337/db23-1056-P Presented at the American Diabetes Association (ADA) conference (added 04/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Study Completion: 2022-04-16
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Sub-study A:
1. Aged 18 and over.
2. Has Type 1 or Type 2 Diabetes.
3. HbA1c >/=64;
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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sub study A:<br>1. Eligibility rate recorded as number of screened patients who were eligible against inclusion/exclusion criteria per month. <br>2. Recruitment rate recorded as number of eligible patients who consented to participate in the study by 4 months. <br>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.<br>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. <br>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).