Recovery from non-severe hypoglycaemia in adults with type 1 diabetes using insulin therapy. Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a single-centre, open-label, randomised, two-period crossover study in adults with type 1 diabetes. Participants are are assigned sequential study identification numbers and randomised before
telephone Visit 2 (independent single-product questionnaire completion for the first treatment, treatment switch, Week 6)
in-person Visit 3 (independent single-product questionnaire for the second treatment, direct head-to-head comparative questionnaire, and structured exit interview, Week 12).
Continuous glucose monit
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants who can adequately understand verbal and/or written explanations given in English 2. Participants under 75 and over 18 3. Diagnosis of type 1 diabetes for greater than 12 months 4. HbA1c >40- 86 mmol/mol 5. Able to comply with the study 6. Patients who are or who have previously been involved in research are eligible, provided a participant has not received an investigational drug within one month of entry into the study 7. Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities
Exclusion criteria
Exclusion criteria: 1. Outside of stated age range 2. Participants without diabetes 3. Females who are pregnant, breastfeeding or intend to become pregnant or are of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) 4. Participation in any clinical trial of an investigational medicinal product within 30 days before screening 5. Inability to understand verbal and/or written explanations given in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported treatment effectiveness and recovery experience following treatment of real-world non-severe hypoglycaemic episodes, measured using structured questionnaires and exit interviews at Week 6 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic outcomes including post-hypoglycaemia time-in-range (4–10 mmol/L) and recurrent hypoglycaemia in the 2-hour recovery window, and overall time-in-range and time below range measured using continuous glucose monitoring via participants' personal CGM devices at across the 12-week study period | — |
Countries
England, United Kingdom
Contacts
Public ContactDavid Russell-Jones
Outcome results
None listed