Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
All participants will participate in an educational programme which has been validated in our single centre pilot study. This includes carbohydrate counting, discussion on glycaemic indices of food, t
Sponsors
Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 - 74 years 2. Established type 1 diabetes mellitus (C peptide negative) 3. Experienced impaired hypoglycaemia awareness and, or at least one episode of severe hypoglycaemia as defined as by the American Diabetes Association in the previous 12 months 4. Willing to undergo intensive insulin therapy including the use of CSII (insulin pump) 5. Willing to monitor home blood glucose levels at least four times daily 6. Willing to monitor and record signs and symptoms of hypoglycaemia
Exclusion criteria
Exclusion criteria: 1. Not willing to consider insulin pump therapy 2. Unable to use the technology such as real time glucose monitoring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restoration of hypoglycaemia awareness as determined by quantitative questionnaire analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in rates of mild symptomatic hypoglycaemia as measured by home blood glucose diaries at 6 months and intermediate study visits 2. Difference in duration of biochemical hypoglycaemia determined by 7-day continuous glucose monitoring system (CGMS) at 6 months and intermediate study visits 3. Difference in HbA1c at 6 months and intermediate study visits 4. Difference in rates weekly 8-point glucose profiles | — |
Countries
England, United Kingdom
Outcome results
None listed