Technology-enhanced, culturally-informed primary care results in sustained improvements in biomarkers for Indigenous patients with type 2 diabetes – a pilot study
Lynne M. Chepulis
1 * , Rebekah Crosswell 1 , Suzanne Moorhouse 2 , Helen Morton 3 4 , Michael Oehley 4 5 , Ryan Paul 1 6 , Hamish Crocket 1
1
2
3
4
5 Present: Medical Advisor,
6
Abstract
Type 2 diabetes disproportionately affects Indigenous Māori in New Zealand. The reasons for this are multifactorial but include a history of colonialism, barriers to health care access and a lack of culturally appropriate interactions/relationships with health care providers. There is currently a need to develop models of health care delivery that are tailored to the needs of this population.
This pilot study evaluates the use of technology, education and culturally-informed wrap-around care (including medication optimisation) to improve type 2 diabetes biomarkers and self-management in a high-needs, majority Indigenous population.
Twenty-three participants with HbA1c >80 mmol/L received 2–4 weeks of continuous glucose monitor (CGM) wear at baseline and at 3 months alongside culturally-informed type 2 diabetes education and clinical care. Clinical biomarkers and psychometric measures were recorded at 0, 3, 6 and 12 months and 0 and 3 months respectively. Medication changes were recorded throughout the study.
Mean (± s.d.) HbA1c significantly decreased from 93.4 ± 15.7 mmol/mol at baseline to 76.5 ± 14.8 mmol/mol at 3 months, with reductions maintained at 6 and 12 months by approximately three-quarters of participants (all P < 0.001 vs baseline). Diabetes self-management and LDL-cholesterol measures also improved significantly at 3 and 12 months, respectively.
CGM informed, culturally-appropriate care has the potential to lead to sustained improvements in glycaemia in high-risk, Indigenous populations managed in primary care.
Keywords: CGM, continuous glucose monitors, culturally-informed care, diabetes medications, general practice, health systems research, Indigenous, Māori, primary care, type 2 diabetes.
| WHAT GAP THIS FILLS |
| What we already know: Type 2 diabetes disproportionately affects New Zealand Māori; however, current primary health care service delivery does not meet the needs for many. Continuous glucose monitors (CGMs) can support management of type 2 diabetes, although studies suggest that glycaemic improvements resulting from CGM use alone are often not sustained longer term. |
| What this study adds: A model of health care delivery that uses CGMs within a culturally-informed program of education and optimised health care delivery improves glycemia in the short term, with improvements maintained by most for at least 12 months. This model demonstrates the value of using culturally-informed health care delivery to support improvements in health equity. |
Introduction
Indigenous populations are disproportionately affected by type 2 diabetes1 and in New Zealand (NZ), Indigenous Māori have both a higher prevalence of type 2 diabetes and adverse health outcomes compared to NZ Europeans.2,3 Studies suggest that continuous glucose monitoring (CGM) can support type 2 diabetes management by providing opportunities to recognise how daily activities (eg diet and exercise) impact on glycaemic control;4 however, there is a dearth of clinical trials evaluating its efficacy of use in Indigenous peoples, despite the fact that these groups have higher rates of complications and mortality than their non-Indigenous counterparts.5 For Indigenous peoples, culturally-informed education and care are essential to address social and familial concerns and to promote patient empowerment and longer-term goals.6 Thus, this study aims to evaluate the use of CGM within a primary-care led programme of care that utilises culturally-informed education and ‘wrap-around’ care to improve type 2 diabetes outcomes in patients with high risk glycaemia.
Methodology
Study participants
Patients enrolled with Raukura Hauora O Tainui (a Māori primary care provider in the Waikato region of New Zealand) during 2022–2023 with type 2 diabetes diagnosed ≥12 months ago and an HbA1c ≥80 mmol/mol were invited to participate in this 12-month, single-arm pilot study. Patients with co-morbidities were included (as recorded in the patient’s medical file), however, exclusions included pregnancy, renal failure, cancer and any conditions/regular medications known to impact glycaemic control. Recruitment prioritised for Māori ethnicity (as coded in primary care records), and eligible patients were identified and contacted by a member of the clinical team.
Study procedure
Potential participants were contacted by a Māori kaiāwhina (a non-accredited health worker grounded in Māori cultural practice). The focus of initial meetings between kaiāwhina, participants and their whānau (family) were to establish a culturally-centred relationship based on the principles of whakawhanaungatanga (connection), whakapapa (family connections), rangatiratanga (self-determination), Kotahitanga (unity/togetherness), manaakitanga (kindness/respect) and kaitiakitanga (guardianship).
After an initial meeting to establish a kaiāwhina–patient connection and to gain signed consent, further information was collected about the patient/whānau (iwi, self-reported level of diabetes knowledge, whānau history of diabetes, day-to-day lifestyle and diabetes management habits (blood glucose testing frequency, medications, exercise frequency and common dietary information), as well as any personal goals for the type of education to be delivered). Baseline bloodwork consisting of glycated haemoglobin (HbA1c), lipids, urinary albumin creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR). Co-morbidities and medication use were also recorded. Following this, participants were offered 4 weeks wear of a continuous glucose monitor (either Freestyle Libre 1.0 or 2.0, Abbott Diabetes Care Ltd) – using either a study phone, their own phone or a receiver to record the data. Participants were asked to use an app to maintain a photo-based food diary (Foodview Pty Ltd.) and ‘to experiment’ with food choices during the first 2 weeks to learn about the impact of different foods on glucose levels.
During the period of continuous glucose monitor wear, the kaiāwhina provided home visits every 3–4 days to provide education relevant to type 2 diabetes about diet, exercise and lifestyle to participants and their whānau (family). This included the definition/explanation of HbA1c, food and nutrition information (carbohydrates, sugars, food labels), sick day management, importance of medication as well as review of the participants CGM data (in Libreview) alongside any information about their timing of food and/or exercise. Specific resources used included those from Diabetes NZ (eg the Healthy Plate Model, Living Well with Type 2 Diabetes, Foot Care), the Healthify website and resources and other New Zealand-based resources (resources were used in both English and Te Reo Māori [Māori language]). Physical activity advice was tailored to the patient.
Participants were also encouraged to engage with the clinical team to ensure optimal use of medications, including SGLT2i/GLP1RA agents which were funded in NZ for use in type 2 diabetes from February 2021.7 Up to four free health care appointments were provided to participants to facilitate medication titration, clinical reviews and to encourage positive therapeutic relationships with health care providers. There was support from kaiāwhina, as required, for transport, health care access and referral to social support services. Freestyle Libre outputs were uploaded to the cloud and were accessible by the clinical team to support medication initiation and/or titration during periods of CGM. Kaiāwhina also discussed these CGM outputs with participants. A fortnight of additional continuous glucose monitor wear and kaiāwhina support was provided at 12–13 weeks to reinforce the learning and self-management changes (eg any changes to diet, physical activity, medication use and/or health hcare access) achieved during the first 4 weeks.
HbA1c and lipids were collected at 0, 3, 6 and 12 months (primary outcomes). The Diabetes Self-Management Questionnaire (DSMQ)8 and Patient Reported Outcomes Measurement Information System Global Health (PROMIS Global Health)9 were collected at 0 and 3 months by the kaiāwhina. Any additional biomarkers requested by clinicians were also recorded. The DSMQ is a 13-item questionnaire that is intended to measure self-care practices that impact HbA1c. The DSMQ has four subscales: glucose management, dietary control, physical activity and health care use. The subscales and overall score are calculated out of 10, with a higher score indicating better self-management and scores below six indicating sub-optimal diabetes self-management. PROMIS Global Health is a 10-item questionnaire that covers physical, mental and social health.
This study was approved by the University of Waikato Human Research Ethics Committee (Ref: HREC(Health)2022#01).
Statistical analysis
Data are presented as the mean ± s.d. Paired t-tests were used to compare values at 3, 6 and 12 months against baseline, while a chi-squared test was used to compare the proportion of patients using medications. SGLT2i and GLP1RA agents were reviewed as a combined category as NZ patients may only be funded for one or the other at any point in time, but they may alternate between agents. A P-value of <0.05 was considered to be statistically significant. Analysis was completed using R software (R4.3.3).
Results
Twenty-three participants commenced the pilot study (21 Māori, one Pacific and one NZ European; 14 females/9 males). Twenty-one participants were still enrolled in the study at 6 months (one participant moved overseas and one passed away (pneumonia; unrelated to the study)) and 18 participants remained at 12 months (one withdrew due to illness and two voluntarily withdrew). The mean age of participants at baseline was 50.6 ± 9.4 years, and the mean duration of type 2 diabetes at recruitment was 10.9 ± 8.8 years.
Co-morbidities at baseline include morbid obesity and obesity (n = 11), hyperlipidaemia (n = 6), hypertension (n = 6), asthma (n = 6), anxiety and depression (n = 4), gout (n = 3), diabetic nephropathy (n = 3), hypothyroidism (n = 2), cardiovascular disease (n = 2), fibromyalgia (n = 1), non-alcoholic fatty liver disease (n = 1), chronic hepatitis (n = 1) and irritable bowel syndrome (n = 1). Patients remained under the usual care of their general practitioner throughout the study and conditions were managed accordingly.
Mean HbA1c significantly decreased by 16.3 mmol/mol at 3 months compared to baseline (P < 0.01), and mean reductions of at least 18.5–22.1 mmol/mol were sustained at 6 and 12 months (both P < 0.001; Table 1). SGLT2i/GLP1RA use was initiated in 7 of the 14 naïve patients. Insulin was used by eight patients at baseline but not initiated in any further patients during the study (Table 1).
| Measurement | Baseline | 3 months | 6 months | 12 months | P-values | |||
|---|---|---|---|---|---|---|---|---|
| 3 months vs baseline | 6 months vs baseline | 12 months vs baseline | ||||||
| Medication use | ||||||||
| Patients using insulin | 8/23 | 8/23 | 8/21 | 8/18 | 1.000 | 0.817 | 0.532 | |
| Patients using SGLT2i/GLP1RAA | 9/23 | 15/23 | 15/21 | 15/18 | 0.079 | 0.070 | 0.012 | |
| Clinical biomarkersB | ||||||||
| HbA1c l (mmol/mol) | 94.3 ± 15.7 | 76.0 ± 14.8 | 72.2 ± 15.9 | 75.2 ± 17.7 | <0.001 | <0.001 | <0.001 | |
| LDL-c (mmol/L) | 3.2 ± 1.0 | 3.0 ± 1.0 | 2.8 ± 1.1 | 2.3 ± 0.8 | 0.831 | 0.138 | <0.001 | |
| HDL-c (mmol/L) | 1.4 ± 0.5 | 1.3 ± 0.3 | 1.4 ± 0.6 | 1.4 ± 0.9 | 0.371 | 0.474 | 0.518 | |
| Triglycerides (mmol/L) | 3.8 ± 2.4 | 3.0 ± 1.4 | 2.7 ± 1.4 | 2.6 ± 2.3 | 0.515 | 0.161 | 0.098 | |
| Total cholesterol (mmol/L) | 6.1 ± 1.2 | 5.5 ± 1.3 | 5.1 ± 1.2 | 4.6 ± 1.1 | 0.051 | 0.011 | 0.194 | |
| UACR (μmol/L) | 80.7 ± 34.5 | 82.3 ± 40.3 | 77.5 ± 37.5 | 84.3 ± 42.0 | 0.877 | 0.888 | 0.724 | |
| eGFR (mL/min.1.73 m2) | 79.2 ± 18.8 | 78.0 ± 19.3 | 78.0 ± 19.1 | 75.6 ± 20.9 | 0.312 | 0.520 | 0.388 | |
| Psychometric scores | ||||||||
| DSMQ | 4.0 ± 1.2 | 6.2 ± 1.1 | – | – | <0.001 | – | – | |
| PROMIS | 32.9 ± 5.8 | 33.0 ± 6.9 | – | – | 0.309 | – | – | |
SGLT2i, sodium glucose co transporter 2; GLP1RA, Glucagon-like peptide-1 agonist; UACR, urinary albumin creatinine ratio; eGFR, estimated glomerular filtration rate; DSMQ, diabetes self-management questionnaire; PROMIS, Patient-Reported Outcomes Measurement Information System.
Individual changes in HbA1c at 0, 3, 6 and 12 months were variable. Of the 18 participants still enrolled at 12 months, five participants (27.8%) had an increase in HbA1c at 12 months compared to baseline (mean increase 9.6 ± 6.9 mmol/mol) and four of these were already being routinely prescribed a SGLT2i or GLP1RA agent at the time of commencing the study. Of the remaining 13 people, 10 had a 12-month reduction in HbA1c of at least 20 mmol/mol compared to baseline (mean reduction 30.4 ± 15.5 mmol/mol).
Mean total and LDL cholesterol were both significantly reduced at 12 months compared to baseline (P < 0.05; Table 1), although no significant changes were seen for triglycerides and UACR levels at 3 and 6 months. DSMQ scores improved from a baseline mean of 4.0 ± 1.5 to 6.2 ± 1.1 at 12 weeks (P < 0.001), with 12 participants scoring above six (optimal control) for glycaemic management and health care use at 3 months. No significant differences were observed in PROMIS scores (see Table 1).
Conclusions
CGM use coupled with culturally-informed delivery of education and support to access health care appears to be an effective model for supporting Indigenous patients with type 2 diabetes, significantly reducing HbA1c, LDL and total cholesterol and improving diabetes self-management. Importantly, HbA1c reductions achieved within the first 3 months were sustained longer-term by the majority of participants, despite this being a high-risk population. As seen in other studies,4,10 CGM may be an important tool for supporting patient understanding of daily glucose management (including the impact of different foods and exercise), while also supporting clinicians to effectively manage medication titration. This suggests that there is value to intermittent use of CGM as an educational tool in primary care to support education about broad aspects of self-management of type 2 diabetes, rather than continual wear of a continuous glucose monitor.
Primary care-led wrap-around care was also an integral component of our proposed model of care, and specific components of this that may have enabled improved measures included home-based health care delivery, free doctor appointments and facilitated relationships with clinical staff. Furthermore, as a result of increased health care access, the majority of participants appear to have had their glucose lowering medications optimised with most having initiated a SGLT2i or GLP1RA agent by 12 months. This is an important finding as these drugs are known to reduce HbA1c by 1% (11 mmol/mol) in as little as 3 months.11
Whilst only a single-arm, non-randomised pilot study, these results demonstrate the efficacy and potential of this model of care for achieving health equity for Indigenous people with type 2 diabetes. Larger studies (eg a randomised controlled trial and cost–benefit analyses) are urgently required to (i) confirm the statistical results/findings in this study; (ii) determine the impact of the different study components on improved health outcomes (eg CGM vs kaiāwhina/cultural support vs initiation of SGLT2i/GLP1RA medications), (iii) evaluate how this model of care can be integrated within a standard primary care type 2 diabetes management programme, and (iv) assess whether improvements in clinical outcomes can be maintained longer than 1 year. Additionally, as few psychometric scales have been validated with Māori populations, validation studies of tools such as the DSMQ with Māori would be beneficial. The role of SGLT2i/GLP1RA also needs to be evaluated in Indigenous Māori patients with type 2 diabetes (including as separate medication categories), given their significant impact on weight loss, glycaemia and cardiorenal disease risk,12,13 clinical inertia to use14 and the fact that Māori patients with type 2 diabetes have prioritised funded access to these agents in NZ.7 Accurate recording of weight/BMI pre- and post-intervention should also be included in future studies, and more work is required to explore how patients already on optimised medications can be further supported to achieve improved health outcomes.
Data availability
The dataset generated during and/or analysed in the current study is available from the corresponding author upon reasonable request.
Acknowledgements
We would like to thank Ms Salem Waters and Mrs Donna Foxall for supporting different aspects of this study. We also thank the staff at Raukura Hauora O Tainui for facilitating this study.
Author contributions
L. C. designed the study, sought funding and managed the study throughout along with H. C. R. C. was the primary researcher on the project, undertaking the weekly engagements with participants. S. M., H. M., M. O. and R. P. are all registered clinicians who participated in this study, supporting participant recruitment, review of clinical data and optimisation of prescribing. L. C. drafted this work for publication, all authors contributed to the manuscript and all approve this work for publication.
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