None listed
Conditions
Brief summary
65 volunteers aged 2-80 years with type 1 diabetes will take part in this open label extension study. After baseline assessments and two run-in periods of increased automation (where the pump increasingly controls your child’s blood glucose levels), the participants will then undergo a 6-month period of using the insulin pump in its trial settings (fully automated with optimisation of settings every 21 days). The new insulin delivery method being tested in all patients in this study is the Medtronic AHCL system running in the fully automated AHCL mode. The primary outcomes are to compare the proportion of time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) - The Medtronic insulin pump running in advanced hybrid closed loop (AHCL) mode - The Medtronic insulin pump running as sensor augmented pump therapy (SAP) with predictive low-glucose management (PLGM). Our secondary outcomes will include -longer term glycaemic control while using AHCL as measured by glycated haemoglobin (HbA1c) at 3 and 6 months compared to pre-study baseline. - longer term safety (as defined by severe hypoglycaemia, Diabetic ketoacidosis, adverse device events (expected and unexpected). We will also analyze Sleep Quality by conducting the PSQI questionnaire and evaluate the lived experience of patients using AHCL by conducting a qualitative questionnaire.During the lead in phases participants will be required to upload their insulin pumps on a weekly basis. On initiation of auto-mode, participants will be required to upload daily for the first seven days. The study will be conducted in Canterbury and Otago.
Interventions
This is a single arm longitudinal study investigating advanced hybrid closed loop insulin therapy (AHCL) combined with an optimisation protocol. For the duration of the study participants will be provided with a Medtronic AHCL pump.
The pump works in Manual Mode (comparable to current insulin therapy with the Medtronic 640G pump) and Auto Mode (hybrid closed loop therapy).
Participants will be educated using both face to face verbal instruction and printed sponsor derived instruction manuals(
This is a single arm longitudinal study investigating advanced hybrid closed loop insulin therapy (AHCL) combined with an optimisation protocol. For the duration of the study participants will be provided with a Medtronic AHCL pump. The pump works in Manual Mode (comparable to current insulin therapy with the Medtronic 640G pump) and Auto Mode (hybrid closed loop therapy). Participants will be educated using both face to face verbal instruction and printed sponsor derived instruction manuals(from Medtronic) on the use of Auto Mode, an option available in the pump, which will adjust the insulin delivery based on the sensor glucose level. The user will still need to bolus for meals like standard pump therapy and hence this is described as a hybrid closed loop system. The interventions(s) will be administered by an Endocrinologist(independent of clinical treatment team) together with two research nurses. Following a run-in period of 21 days running as a sensor augmented pump(SAP) with Predictive low Glucose Monitoring (PLGM) to allow Automode activation, participants will then run non-optimized advanced hybrid closed loop . After these two phases, all participants will enter into the optimisation phase to complete 6 months AHCL study duration total. Optimization occurs with a mathematical model-based digital-twin tool to personalize and automate user-dependent AHCL .The inputs to this model are carb-insulin ratio, active insulin time, manual mode, basal rates. The tool uses a minimum of 21 consecutive CareLink days of sensor augmented pump therapy to generate the following outcomes: • 48 segments for Manual Mode basal rates (00:00 - 00:30, 00:30 - 01:00, etc.) • 1 ISF for Manual Mode to match the Insulin sensitivity factors utilized by the Auto Mode • 8 segments for Manual Mode and Auto Mode Carbohydrate ratios (00:00-03:00, 03:00 -06:00, etc.) • active insulin time (AIT) for manual mode and Auto Mode. Participants will be recommended to electronically upload their insulin pump weekly for the first 6 weeks, to a cloud based server with additional input with the study team, will refine pump settings according to the recommendations. After 6 weeks, the minimum upload and optimization frequency is every 14 days, but can occur with greater frequency as per discretion of the investigators and subjects. At these upload points the study staff will access pump analytics including time in auto mode and reasons for auto mode exit, as well as amount of insulin used , basal rates, bolus insulin used and blood glucose levels. Therefore these reviews will be used to monitor adherence to the intervention. The single arm study intervention is: Medtronic AHCL insulin pump running in AHCL mode with associated optimisation protocol Expected duration of subject participation is 8 months (6 months + 42 days run-in) The optimisation intervention is a mathematical model-based digital-twin tool, using the previous 21 days data from the AHCL upload on CarelinkTM will generate suggested setting changes (see detail below).
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
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 2 – 80 years inclusive. 2. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1. 3. On insulin pump therapy for at least 6 months prior to trial. 4. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. 5. Willing and able to adhere to the study protocol. 6. Access to the internet and a computer system that meets requirements for uploading the study pump.
Exclusion criteria
1. Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test). 2. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted). 3. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit. 4. Current use of SGLT-2 or GLP-1 medications. 5. History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator. 6. History of severe visual impairment, in the opinion of the Investigator. 7. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary. 8. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Outcome results
None listed