Improving Outcomes Among Young Adults with type 1 diabetes: The D1 Now Randomised Pilot Study Protocol.
Bláthín CaseyM ByrneD CaseyP GillespieA HobbinsJ NewellE MorrisseySéan F DinneenPublished in: Diabetic medicine : a journal of the British Diabetic Association (2020)
Diabetes clinics on the island of Ireland will be recruited and randomised to a D1 Now intervention arm or a usual care control arm. For a participant to be eligible they should be 18-25 years old and living with type 1 diabetes for at least 12 months. Participant outcomes (influenced by a Core Outcome Set) include change in HbA1c, clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes; these will be will be measured at baseline and after 12 months follow-up for descriptive statistics only. An assessment of treatment fidelity, a health economic analysis and a qualitative sub-study will also be incorporated into the pilot study. ISRCTN (ref: ISRCTN74114336).
Keyphrases
- type diabetes
- glycemic control
- cardiovascular disease
- young adults
- clinical trial
- healthcare
- randomized controlled trial
- primary care
- open label
- mental health
- public health
- double blind
- study protocol
- palliative care
- depressive symptoms
- physical activity
- skeletal muscle
- metabolic syndrome
- combination therapy
- pain management
- weight loss