Type 1 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
The D1 Now Study employs a cluster-randomised controlled trial design, where participating diabetes clinics (clusters) are randomly assigned to either the intervention or control arm. Randomisation (b
Sponsors
Ollscoil na Gaillimhe – University of Galway
Eligibility
Sex/Gender
All
Age
18 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Currently registered to the outpatient diabetes clinic at a participating centre 3. Individuals with a confirmed diagnosis of type 1 diabetes for more than 12 months 4. Individuals aged 18 through 25 years at the time of recruitment
Exclusion criteria
Exclusion criteria: 1. Individuals who participated in the D1 Now pilot RCT 2. Individuals who are pregnant/planning to become pregnant during the intervention period 3. Individuals who are unable to communicate in English 4. Individuals who were or are currently members of the D1 Now Young Adult Panel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in blood glucose control measured via a central laboratory HbA1c assay at baseline and at a 12-month follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| The effectiveness of the D1 Now intervention on clinical outcomes: 1. Diabetes-related distress is measured using the Problem Areas in Diabetes-11 (PAID-11) at month 0 and month 12 2. Diabetes-related quality of life is measured using the Audit of Diabetes Dependent Quality of life (ADDQOL) at month 0 and month 12 3. Self-management is measured using the Diabetes Self-Management Questionnaire (DSMQ) at month 0 and month 12 4. Level of clinic engagement is measured using clinic attendance and obtained from the clinic administration system at month 0 and month 12 5. Perceived level of control is measured using the Diabetes Empowerment Scale – Short Form (DES-SF) at month 0 and month 12 6. The number of instances of diabetic ketoacidosis (DKA) over the previous 12 months is measured using the definition ‘an episode of hyperglycaemia, ketoacidosis and ketonuria requiring hospital admission and care’ and obtained from both the medical notes and through self-report at month 0 and 12 7. The number of instances of severe hypoglycaemia over the previous 12 months is measured using the definition ‘an episode of hypoglycaemia that requires assistance from another person to treat’ and obtained through self-report at months 0 and 12 8. The frequency of stigmatising experiences among young adults with Type 1 diabetes measured using the Diabetes Stigma Assessment Scale (DSAS-1) at months 0 and 12 9. A process evaluation to examine the implementation and delivery of the D1 Now intervention and the overall trial processes at 12 months 10. The mechanisms of impact are assessed using a bespoke questionnaire developed by the D1 Now study team at month 0 and month 12 11. Participants' perceptions and experiences with the D1 Now intervention and usual care explored through semi-structured interviews with participants and staff at 12 months 12. The cost-effectiveness of the D1 Now intervention through a detailed health economic analysis, comparing it to usual care in terms of resource uti | — |
Countries
Ireland
Contacts
Public ContactSean Dinneen
Outcome results
None listed