None listed
Conditions
Brief summary
The objective of this study is to assess the impact of automated insulin delivery from diagnosis on glycaemic measures at 12 months after diagnosis, compared to non-Maori/Pacific Peoples. The primary outcome to be measured will be the percentage of Maori and/or Pacific Peoples attaining HbA1c below the international recommended target of <53mmol/mol at 6- and 12-months post diagnosis. The secondary objectives include multiple measures of equity. These include technology use at 12 months, clinic attendance (orepisodes of HCP contact)/non-attendance rates, episodes of hospital admissions (diabetes related and unrelated), and qualitative measures using kaupapa Maori methodology. It is hypothesised that with the introduction of automated insulin delivery early in the patients journey with Type 1 diabetes, the long term management of their diabetes will be better than is seen historically where automated insulin delivery occurs at least 12 months following diagnosis.
Interventions
Participants newly diagnosed with type 1 diabetes will be enrolled in the study and begin their diabetes journey using evidence-based intensive management strategies. These include multiple daily injections (with flexible dosing according to carbohydrate intake and glucose level) and continuous glucose monitoring (CGM). Early transition onto Automated Insulin Delivery (AID) will occur within 3
months of diagnosis. Participants will use an YpsoPump compatible CGM and an YpsoPump running in AID
Participants newly diagnosed with type 1 diabetes will be enrolled in the study and begin their diabetes journey using evidence-based intensive management strategies. These include multiple daily injections (with flexible dosing according to carbohydrate intake and glucose level) and continuous glucose monitoring (CGM). Early transition onto Automated Insulin Delivery (AID) will occur within 3 months of diagnosis. Participants will use an YpsoPump compatible CGM and an YpsoPump running in AID utilizing the CamAPS FX algorithm. During the first 7 days of using AID, daily electronic review will occur to ensure safety. Investigators will adjust settings if the participants’ time spent <3.5mmol/L is not less than 4%, and time spent >15mmol/L is not less than 30%, or if the investigator has any other safety concerns. Participant involvement will include the wearing of a compatible continuous glucose monitor (CGM) and insulin pump. Both the CGM and insulin pump used are available for full Pharmac funding as of the 1-Oct-2024. The algorithm used in this system will be the CamAPS FX closed loop system, also fully funded through PHARMAC. Initial pump settings will be determined by the study Endocrinologist. AID use will commence in the first 3 months post diagnosis and continue from initiation, up to 12 months post diagnosis. Follow-up appointments following pump initiation will align with normal clinical appointments at 3, 6, 9, and 12 months. System settings will be reviewed by the study doctor and changed as needed. With glucose control reviewed remotely to monitor adherence and need for changes. Data from the CGM and pump will be automatically uploaded to a cloud based server every 24 hours to enable review of data by the study doctor.
Sponsors
University of Otago, Christchurch
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
0 to 25 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Maori and/or Pacific Peoples aged 25 years and under 2. Type 1 diabetes as per the American Diabetes Association Classification. 3. Willing and able to adhere to the study protocol. 4. Access to the internet and a computer system that meets requirements for uploading the pump.
Exclusion criteria
Exclusion Criteria: Allergic or intolerant Humalog® and NovoRapid® insulin
Outcome results
None listed