Can Flash Glucose Monitoring (FlashGM) improve glucose management in Indigenous Australians with type 2 diabetes?

Not Applicable

Recruiting

Conditions: type 2 diabetes
Metabolic and Endocrine - Diabetes

Registration Number: ACTRN12621000753853

Lead Sponsor: niversity of Melbourne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

1.Indigenous Australian
2.Confirmed diagnosis of type 2 diabetes
3.Age greater than or equal to 18 years and above
4.HbA1c greater than or equal to 7.5% (58 mmol/mol) from either a recent blood test (within 4 weeks of screening date) or blood sample taken at screening determined through laboratory pathology testing. *must be laboratory confirmed HbA1c not point of care testing.
5.Medicated with the same type of injectable therapies ± oral hypoglycaemic agents, for at least 6 weeks prior to screening:
i.Insulin alone or with or without oral agents
ii.GLP1 analogues (including subclasses) with or without oral agents
iii.GLP1 analogues (including subclasses) and insulin with or without oral agents.

Exclusion Criteria

1.Age < 18 years
2.Type 1 diabetes mellitus
3.Taking high doses of vitamin C supplements (more than 500 mg per day)
4.Active malignancy requiring chemotherapy
5.Known allergy to medical-grade adhesives
6.On varying doses of corticosteroid therapy
7.Using amphetamines, anabolic or weight-reducing therapies
8.Pregnancy or actively planning pregnancy as HbA1c is not reliable during pregnancy and is the primary outcome.
9.eGFR<15ml/min/1.732 or erythropoiesis stimulating agents or end-stage kidney disease
10.Haemoglobinopathies
11.Active illicit drug use or heavy alcohol use
12.No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c level from baseline to 6 months where HbA1c is measured from the blood sample taken to a local accredited pathology company which services the site. Laboratory measurements of HbA1c will be performed using the standardization of HbA1c measurements recommended by the Royal College of Pathologists Australasia and the Australasian Association of Clinical Biochemists. Bloods will be processed in line with local pathology requirements. For this primary outcome, local point of care testing device will not be appropriate. [ Baseline to 6 months (final visit)]

Secondary Outcome Measures