None listed
Conditions
Brief summary
Automated insulin delivery (AID) is the recognised best treatment for managing glucose in people with Type 1 Diabetes (T1D) and has been shown to greatly improve glucose outcomes. These systems link a pump, glucose sensor and computer algorithm to automate insulin delivery. The systems continuously adjusts insulin to help keep your glucose more stable. Despite this, access to these technologies is slow and not always available to those who need them most. Now that this technology is fully funded for people living with T1D in Aotearoa New Zealand, an estimated 10,000 people are expected to want to transition on to insulin pumps in the next year. However, no way near this number are currently being given access to insulin pumps each year in NZ. The purpose of this study is to provide a remote ‘Hub’, as a new model for health delivery, to assist the healthcare system successfully transition individuals with T1D onto AID. We anticipate this will allow individuals in regions struggling with staffing to allow pump starts earlier access to pumps than they would normally receive.
Interventions
This is a quasi-experimental, single-arm study. A remote national Hub model will be deployed to provide prioritized national AID set up and support, before transferring participants back to their usual care teams when stable. AID systems link an insulin pump, glucose sensor and computer algorithm to automate insulin delivery. The systems continuously adjusts insulin to help keep blood sugars more stable. This study will use fully funded and commercially available insulin pumps in New Zealand.
This is a quasi-experimental, single-arm study. A remote national Hub model will be deployed to provide prioritized national AID set up and support, before transferring participants back to their usual care teams when stable. AID systems link an insulin pump, glucose sensor and computer algorithm to automate insulin delivery. The systems continuously adjusts insulin to help keep blood sugars more stable. This study will use fully funded and commercially available insulin pumps in New Zealand. The ACCESS-AID remote hub will be staffed by a multidisciplinary Clinical Team and supported by the wider research team (who all support individuals with T1D) which includes Adult and Paediatric Endocrinologists, Nurse Practitioners, Diabetes Nurse Specialists, Dietitians and experienced Diabetes Research Staff. Key roles within the Clinical Team include a Remote Hub Manager, Medical Lead, Nursing Lead, Clinical Staff and Dietitian. Clinical staff will be registered Allied Health Professionals, mostly nurses, diabetes nurse specialists, dietitians and/or pharmacists. The day to day running of the Hub will be led by the Hub Manager. Interactions with participants enrolled in the Hub to provide clinical support and follow up will be led by the Nursing Lead and Clinical Staff. The Medical Lead will provide medical oversight to the Clinical Team. The Dietitian(s) will provide nutrition related oversight and carbohydrate awareness/counting education as required. Care provided by the Clinical Staff wil be differ from that provided by usual health care providers. Rather, this model of care will streamline the process so provide quicker and more equitable access to AID systems. For this study, a participants usual care team refers to the health professionals which usually oversee their diabetes related care (e.g., diabetes clinic, GP, etc.). Any member of the participants usual care team will be able to refer them to the ACCESS-AID hub. During enrolment in the ACCES-AID Hub, participants usual care teams will be invited to attend study visits (e.g. the Telehealth consult), however this is optional. At the end of participants enrolment in the Hub, usual care teams will continue with diabetes related care. The duration from enrolment in the Hub, until transfer back to usual care teams is expected to be 4-months, but can vary based on need. Glycaemic data will be reviewed remotely at 6-months (after participants have been transferred back to usual care teams), to monitor sustained improvements in glycaemic control, after which point participants will be removed from the study's online diabetes management accounts (i.e., after this point study staff can no longer access participant data). The duration from referral to enrolment may vary depending on participants prioritisation score. Referral to Hub: Data included in referral will be used to calculate prioritisation score, which will determine time to enrolment in Hub. Day -28 (+ 14 days): Enrolment in Hub - Informed consent: participant provided with electronic participant information sheet or physical copy via post if online unavailable. Team member to phone participant to explain study and answer any questions. Link sent to obtain electronic consent. - Commence collection of biochemical data including: HbA1c and traditional CGM metrics. If participants have not had biochemical tests completed as a part of a Diabetes Health Screen in the previous 12-months from enrolment, urinary albumin:creatinine ratio, renal function and lipid studies may also be completed. Completion of baseline questionnaires including Diabetes Treatment Satisfaction Questionnaire (DTSQ) and EQ-5D (a measure of health status) and an only carbohydrate counting assessment tool. A referral to an optional group or individual carbohydrate counting/awareness education session with study dietitian will be completed if the score from carbohydrate counting assessment indicates need for additional support. - Telehealth Consult with Hub staff to confirm selection of AID system (funded systems commercially available in NZ) and commencement of appropriate CGM (if not already using). Hub team to confirm initial pump settings determined from at least 2 weeks of CGM data and baseline biochemical and physical data. Arrange pump start with supplier Initial settings to be sent to company representative in advance of AID training. Day 0: Commencement of AID following in-person AID training provided by an external company (device distributer who are trained to provide pump specific training). Day 0 to 12-weeks: Remote review by Hub staff daily for the first three days, then twice weekly for a week, weekly for three weeks and then monthly ending at 12-weeks. 12-weeks: Collection of biochemical data including: HbA1c and traditional CGM metrics; completion of online questionnaires including: DTSQ and EQ-5D. End of enrolment in Hub and transfer back to usual care teams. 12-16 weeks: A sub-group of enrolled participants, and health professionals from their usual care teams, will be invited to participate in semi-structured, face to face qualitative interviews to explore acceptability of the remote hub as a new model of care, as well as experience using AID. 6 months: Remote review of CGM data. Note: Timeline from enrolment to AID start will vary depending on prioritised capacity and previous CGM data use/availability. We anticipate a maximum of 4 weeks from pump selection to AID start.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Individuals diagnosed with type 1 diabetes. Suitable health care team available for transfer of care at the end of enrolment in study.
Exclusion criteria
Individuals who are pregnant will not be eligible to be enrolled in the Hub (these individuals will be able to access an insulin pump through existing health delivery pathways). Additionally, those who have non-diabetes moderate-severe health / mental health issues that are active, would be referred to appropriate health care providers first for support and management, before transitioning to diabetes technology. There is no age restriction, however the Clinical Team will ensure suitability of commencement of AID in younger individuals on a case-by-case basis.
Outcome results
None listed