Specialty: Diabetes, Primary sub-specialty: Type 1
Conditions
Interventions
In the first phase of the study, a structured group education programme to provide adults with T1DM with the skills, knowledge and confidence to manage their diabetes before, during and after exercise
Sponsors
Taunton and Somerset NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Health care practitioners inclusion criteria (phase 1): 1. Any HCP involved in the care of patients with type 1 diabetes 2. Testable knowledge about carbohydrate counting and insulin adjustment T1DM inclusion critera (phase 2): 1. Type 1 diabetes 2. Aged 18 - 70 inclusive 3. On basal bolus insulin regime 4. Knowledge of carbohydrate counting 5. Have attended their local approved T1DM education programme (DAFNE, BERTIE, Living with diabetes or equivalent) 6. Doing more than 30 minutes of exercise twice a week or have signed up to do a sporting event (run or cycle event for example) that will take place in the next 3-6 months
Exclusion criteria
Exclusion criteria: T1DM exclusion critera (phase 2): 1. Pregnancy 2. On insulin pump 3. Hypoglycaemia unawareness 4. Inability to provide informed consent 5. Aged under 18 years or 71 years and over 6. Unable to understand English 7. Any psychological disease likely to interfere with the conduct of the study 8. Unable to exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Eligibility rate is determined as the percentage of patients who are contacted about the study who meet the eligibility criteria 2. Recruitment rate is determined from as the percentage of eligible patients who consent to be involved in the study 3. Adherence rate, determined as the percentage of consented patients that attend the education days and all study visits, and drop out rate, determined as the percentage of consented patients who are lost to follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of outcome measures collection, determined from interviews conducted at the end of the study 2. Acceptability of the intervention, determined from interviews conducted at the end of the study 3. Estimates of statistical properties of potential outcome measures that are needed for sample size calculations for the definitive trial. The potential outcomes that will be measured are (all will be measured at baseline and 6 months): 3.1. BMI(Kg/m2) 3.2. Waist circumference (cm) 3.3. Blood pressure 3.4. Percentage fat (bioimpedence) 3.5. Long term glucose control (HbA1c) 3.6. Hypoglycaemia awareness (Gold score, Edinburgh hypo survey, and hypoawareness score, The Hypoglycaemia Fear Survey, Clarke's Hypoglycaemia Awareness Questionnaire) 3.7. Frequency of hypoglycaemia (Blood Glucose monitoring (Roche Xpert Meter) and Continuous Glucose monitoring (dexcom) 3.8. Physical activity measured with an accelerometer (Actigraph model GT3X, Actigraph, Pensacola, Florida, USA) 3.9. Barriers to exercise measured with the “Barriers to Physical Activity in Type 1 Diabetes' (BAPAD-1) scale. | — |
Countries
United Kingdom
Contacts
Public ContactNiamh Quann
Outcome results
None listed