Trial reportBMC health services research2025
Technology-Enhanced KaiāwhiNa-Based support to Optimise type 2 diabetes management in primary care (TEKNO), a randomised controlled trial study protocol.
Trial report in BMC health services research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
10 authors.
Funding
Abstract
backgroundTechnology such as continuous glucose monitors (CGMs) have the potential to dramatically improve diabetes care for people with type 2 diabetes (T2D), but optimised clinical support is also required. This study aims to explore the use of a new kaiāwhina (cultural support worker)-based model of T2D healthcare delivery, with and without the use of CGM, as models of care that can be implemented long-term into primary care.
methodsThis randomised controlled trial will be conducted within one geographical region (Waikato, New Zealand), and will be delivered by two general practice clinic providers (covering seven different clinic sites). A minimum of 90 adults with T2D with suboptimal glycaemic control (HbA1c > 9.5% [80 mmol/mol]) will be assigned by randomisation with minimisation to one of three trial arms for a period of 26 weeks. Intervention 1 consists of intermittant use of CGM plus kaiāwhina plus optimised nurse/prescriber-based clinical care. Intervention 2 consists of kaiāwhina plus optimised nurse/prescriber-based clinical care without CGM. The third arm consists of Usual Care i.e., patient-initiated clinic visits as required and any standard practice-initiated interaction with patients such as recall for medications and diabetes annual review. At 26 weeks, patients from Usual Care will be randomised with minimisation into either Intervention 1 or 2 for a further 26 weeks. The primary outcomes of the study are change in HbA1c at 26 weeks in both Intervention 1 and 2 versus Usual Care. Secondary outcomes include change in HbA1c between Intervention 1 and Intervention 2 (including those assigned to each intervention after completing the Usual Care arm), changes in HbA1c and cardiovascular measures at 12 and 26 weeks, changes in psychosocial test scores (DSMQ, PAID-II and PHQ), cost-effectiveness analysis (cost per quality-adjusted life-years) and targeted interviews with participants and clinicians to explore their respective experiences and perspectives of the two intervention arms. DISCUSSION: This trial has the potential to inform longer-term primary management of T2D, including the efficacy of both optimised clinical activity and technology use to support people with high-risk glycaemia in an equity-centred model of care.
trial registrationThe trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12624000438550) on 10th April 2024.
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