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Glycemic variability in Indigenous and Non-indigenous Australians with type 2 diabetes.

Glycemic variability in Indigenous and Non-indigenous Australians with type 2 diabetes.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000771651
Acronym
GVPayCycle
Enrollment
90
Registered
2023-07-14
Start date
2023-07-15
Completion date
2025-04-07
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 2 diabetes (T2DM) is a very important chronic health condition that impacts Indigenous Australians disproportionately with devastating effects. T2DM is a major contributor to the reduced life span in Indigenous Australians. It is characterized by a younger age at onset and early and aggressive development of micro- (blindness, renal disease and lower extremity amputations) and macro-vascular (cardiovascular disease) complications. The risk of the complications of T2DM – both their development and the propensity for progression is markedly reduced if good glycaemic control can be achieved. Glycated haemoglobin (HbA1c) is traditionally used for assessment of glycaemic control in T2DM but fails to capture intra- and inter-day acute fluctuations in glycaemic excursions (glycaemic variability), which are associated with postprandial hyperglycaemia. Glycaemic variability is an independent predictor of cardiovascular mortality. Recently developed diabetes-related technology, continuous glucose monitors (CGM), can now easily estimate glycaemic variability by providing 24-hour data. Diet is a major aspect of an optimal glycaemic control strategy, but often subject to economic considerations, particularly in Indigenous Australians. The prevalence of food insecurity (a situation when availability of nutritionally adequate and safe foods or the ability to acquire acceptable food in socially acceptable ways is limited or uncertain) in Indigenous Australians is extremely high at 26%, 5-times the national prevalence. In response to food insecurity, individuals and households often develop ‘coping strategies’ including altered dietary patterns (choosing inexpensive high glycaemic simple carbohydrates over complex carbohydrates, fruits and vegetables or excessive food consumption when money is available and starvation when not). While these coping strategies are intuitively likely to impact glycaemic control adversely, the impact of food insecurity on glycaemic control, including glycaemic excursions in Indigenous Australians with T2DM is not known. We propose to investigate the glycaemic variability around pay cycles in Indigenous Australians with T2DM and with and without food insecurity using CGM. Both food insecurity and pay cycles are likely to affect glycaemic control adversely in Indigenous Australians with T2DM by increasing glycaemic variability. The impact of food insecurity and coping strategies on glycaemic control has apparently never been evaluated with 24-hour CGM data anywhere in the world. While this would be a preliminary study, the findings have the potential to make a major impact on both clinical practice (e.g. actively screening for food insecurity, further interventional studies designed to reduce glycaemic variability) and health policy (e.g. implementing food assistance programs and assessing impact on glycaemic variability).

Interventions

All participants will wear a blinded version of a continuous glucose monitoring (CGM) sensor - Freestyle libre Pro IQ for a period of 4 weeks. The glycaemic variability will be compared between those with and without food security (as determined by a validated questionnaire USDA-18). The CGM sensor will be placed on the participant's arm by the research personnel. Each sensor lasts up to 14 days. We will be using a blinded version of this device which is approved for research purposes only and

All participants will wear a blinded version of a continuous glucose monitoring (CGM) sensor - Freestyle libre Pro IQ for a period of 4 weeks. The glycaemic variability will be compared between those with and without food security (as determined by a validated questionnaire USDA-18). The CGM sensor will be placed on the participant's arm by the research personnel. Each sensor lasts up to 14 days. We will be using a blinded version of this device which is approved for research purposes only and automatically measures glucose levels every few minutes. The participant does not need to take any action other than ensuring that the sensor is worn at all times. At the end of 14 days the participant simply has to return the sensor to the research team. This process will be repeated once more so that data for two consecutive fortnights or 28 days will be captured. The CGM sensor will be provided free of cost to the participants during the period of the study. The research staff will educate the participants prior to the sensor being worn. The participant will be provided support and help in case of any difficulty with wearing the sensor. Clinical assessment: 1. Anthropocentric measurements: 1. Weight, 2. Height, 3. Waist and Hip Circumference (This will take ~ 5 minutes). 2. A standardized battery of tests to test cardiovascular autonomic neuropathy consisting of measuring blood pressure and heart rate at rest and in response to light exercise such as sitting/standing, deep breathing and sustained hand grip will be performed and expected to take 20-30 minutes. 3. Blood will be sampled to measure baseline full blood count, urea and electrolytes, liver function, lipid profile and glycated hemoglobin level (this will take ~20 minutes). 4. List of questionnaires: 1. Baseline demographic information, 2. Food Frequency questionnaire (DQES v3.2), 3. Diabetes Distress Score (DDS-17) 4. Gastrointestinal Symptoms Score (PAGI-SYM) 5. Diabetes Bowel Survey (DBSQ) 6. Depression Score (PHQ-9) 7. Depression and Anxiety Score (DASS-21) 8. Michigan Neuropathy Screening Instrument This set of questionnaires will take ~40 minutes in total. Education regarding CGM sensors will take about 25 minutes.

Sponsors

Chinmay Marathe
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Aboriginal and/or Torres Strait Islander and and Non-Indigenous peoples aged 18 to 80 years with T2DM diagnosed as per WHO criteria with or without food insecurity as per USDA (HFSSM) questionnaire, residing in South Australia who are registered with an Aboriginal health clinic and who receive payment (for salaried work or as unemployment benefits) on a fortnightly basis.

Exclusion criteria

Individuals not residing in South Australia, unable to provide informed consent, refusal, or inability to have a CGM sensor applied to the back of the upper arm, or unwillingness to provide informed consent, pregnancy, or receipt of dialysis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026