iving Well With Diabetes: an open-label, single-arm trial of team-based transition to insulin in primary care to improve HbA1c for patients with poorly controlled type 2 diabetes

Not Applicable

Recruiting

• Conditions: Type 2 diabetes (T2D); Metabolic and Endocrine - Diabetes; Public Health - Health service research

• Registration Number: ACTRN12619000840189
• Lead Sponsor: Tongan Health Society Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-12
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 254

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified