Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
Participating centres will be randomised on a 1:1 basis to control (standard DAFNE courses) or the intervention arm (DAFNEplus course) of the trial. As there are numerous stratification variables that
Sponsors
Sheffield Teaching Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (=18 years) 2. Diagnosis of type 1 diabetes for at least 6 months, or post-honeymoon 3. Prepared to undertake multiple daily injection (MDI) therapy and frequent self-monitoring of blood glucose 4. Confirms availability to attend all sessions as part of the intervention 5. Investigator has confidence that the patient is capable of adhering to all the trial protocol requirements
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 31/12/2019: 1. Current use of continuous subcutaneous insulin infusion (CSII) pump therapy 2. HbA1c > 12%/108 mmol/mol (Investigators can use their judgement, informed by standard DAFNE guidelines and in agreement with the trial team, to include participants with HbA1c >12%/108 mmol/mol) 3. Serious diabetic complications (e.g. blindness, renal dialysis). (Investigators can use their clinical judgement, informed by standard DAFNE guidelines and in agreement with the trial team). 4. Other serious co-morbidities e.g. psychosis, diagnosed eating disorder (Investigators can use their clinical judgement, informed by standard DAFNE guidelines and in agreement with the trial team). 5. Previous participation in standard DAFNE course less than 5 years before proposed study enrolment date 6. Unable to hear/speak/understand/read/write in English 7. Unable to give written informed consent _____ Previous exclusion criteria: 1. Current use of continuous subcutaneous insulin infusion (CSII) pump therapy 2. HbA1c > 12% 3. Serious diabetes-related complications (e.g. blindness, renal dialysis), or other serious co-morbidities (e.g. psychosis, diagnosed eating disorder) 4. Previous participation in standard DAFNE course less than 5 years before proposed study enrolment date 5. Unable to hear/speak/understand/read/write in English 6. Unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary biomedical outcome is glycaemic control, defined as the change in HbA1c (using a centralised assay to ensure standardisation), in those entering the trial with HbA1c >7.5% (estimated at 75% of those currently undertaking DAFNE courses based on our research database); Timepoint(s): End of the study The primary psychological outcome is diabetes-specific quality of life, measured using the DAWN Impact of Diabetes Profile at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 31/12/2019: Secondary biomedical outcome: Number of participants achieving either an HbA1c <7.5% (58 mmol/mol) or a decrease in HbA1c of =0.5% (=5.5 mmol/mol) (using a centralised assay to ensure standardisation). These endpoints will be calculated using data collected at baseline and 12 months after the course. Other secondary biomedical outcomes will include: 1. Severe hypoglycaemia, as defined by the American Diabetes Association, denotes severe cognitive impairment requiring external assistance for recovery, both rates and proportion of those affected, measured at baseline at 12 months after the course 2. Diabetic ketoacidosis, both rates and proportion of those affected, collected at baseline and 12 months after the course 3. Weight, measured at baseline and 12 months after the course 4. Body Mass Index, measured at baseline and 12 months after the course 5. Blood pressure, measured at baseline and 12 months after the course 6. Lipids, measured at baseline and 12 months after the course 7. Albumin/ creatinine, measured at baseline and 12 months after the course Psychological outcomes, measured at baseline, course completion, 3, 6 and 12 months: 1. Dawn Impact of Diabetes Profile (DIDP) 2. Problem Areas in Diabetes Scale (PAID-11) 3. Diabetes-specific positive well-being (W-BQ-28) 4. Hypoglycaemia Fear Survey (HFS-11) Process measures: 5. Diabetes Management Experiences Questionnaire (DMEQ) 6. Self-Regulation/Behavioural Regulation Questionnaire (SRQ-T1D) 7. Diabetes Strengths & Resilience Questionnaire (DSRQ) 8. Confidence in Diabetes Scale (CIDS) assesses beliefs about capabilities (self-efficacy). 9. Diabetes Self-Care Behaviours – SCB-T1D 10. Hypoglycaemia Confidence Scale (HCS) 11. Beliefs about consequences of engaging in DAFNE behaviours and weaving diabetes management into everyday routines. 12. The System Usability Score 13. Use and dose received of the DANFEplus programme assessed via logs of attendan | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactElaine Scott
Outcome results
None listed