None listed
Conditions
Brief summary
Living Well With Diabetes is an open-label, single-arm trial that examines the effectiveness of the “Living Well With Diabetes” program in general practice to help patients with poorly controlled type 2 diabetes for whom insulin is indicated move onto insulin in a timely evidence-based manner. To facilitate insulin initiation, this program involves: 1) identifying barriers to insulin initiation and possible solutions 2) providing innovative, ethnic-specific and self-management education group sessions which use support from patients on insulin (patient enablers), diabetes nurses, a dietician and a podiatrist
Interventions
The intervention (our “Living Well With Diabetes” program) will be delivered at our 3 Auckland GP clinic practices. Here, we will deliver a service to our patients (Tongan) using an ethnic-specific (Tongan) model of care that provides for a group approach to insulin initiation and intensification. This model 'care plans' our patients towards self-management and, at a collective level, assists family and communities to achieve their goals. Central to our model is the innovative face-to-face group
The intervention (our “Living Well With Diabetes” program) will be delivered at our 3 Auckland GP clinic practices. Here, we will deliver a service to our patients (Tongan) using an ethnic-specific (Tongan) model of care that provides for a group approach to insulin initiation and intensification. This model 'care plans' our patients towards self-management and, at a collective level, assists family and communities to achieve their goals. Central to our model is the innovative face-to-face group sessions which are geared toward facilitating the delivery of a Self-management Education (SME) approach. In these group sessions, we will cover evidence around insulin initiation, plus interview our patients to identify barriers to starting treatment and possible solutions. To support this, patients will be provided with printed handouts (designed specifically for this study and translated in Tongan) and will be given hands-on demonstrations with insulin delivery systems and insulin titration tools. To facilitate insulin initiation in these sessions, patients on insulin (patient enablers) will speak to those who need to be on insulin, but not started. These patient enablers are the people with similar demographics and health and socio-economic status as the rest of the non-insulin patients. The non-insulin takers will be able to identify with patient enablers, who will talk about their experience with insulin and how it has impacted their life. These sessions (nurse-led) will be coordinated by our team of diabetes nurses, with assistance from a dietician and a podiatrist; and will comprise 15-20 patients per 3 staff members in each session. The SME sessions will each be 90 minutes in duration. They will run 1-2 monthly over the follow-up period (for 2 years) until patient use of insulin treatment is deemed proficient and adherent by the nurses. Exposure to this intervention will be monitored via attendance logs.
Sponsors
Tongan Health Society Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. T2D patients who are insulin-naive. 2. At least 2 oral hypoglycaemic agents (OHA) (eg. metformin, sulphonylurea, TZDs, DPP-4 inhibitor) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary. 3. Doses of the OHAs should be stable for at least 3 months prior to enrollment into the study (or medical practitioner discretion). 4. HbA1c>=7.5% in the last 6 months who are on maximum oral hypoglycaemic agents 5. T2D patients willing to monitor glucose levels at least twice daily
Exclusion criteria
1. Type 1 diabetes 2. Previous or current treatment with insulin (excluding the short term (<2 weeks) use of insulin in acute illness or during hospitalization) 3. Significant cognitive impairment 4. Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin 5. Significant renal impairment (eGFR < 20) 6. Any life-threatening illness 7. Pregnancy or planned pregnancy 8. Breastfeeding 9. Major psychiatric disorder 10. Substance misuse (alcoholism, drug addiction, etc)
Outcome results
None listed