None listed
Conditions
Brief summary
Despite modern treatment, complications of type 1 diabetes (T1D) and a reduced life expectancy continue to be a reality for patients. Irrespective of socioeconomic status, Maori and Pacific people are particularly over-represented in suboptimal health outcomes, which is evident shortly following diagnosis and remains predictive for long-term complications. These groups may have the most to gain from newer automated technologies. To test our hypothesis that automation of insulin delivery via AHCL will safely facilitate improvements in glycaemic control and reduce disease burden in Maori and Pacific adults with out-of-target glycaemic control and naïve to closed loop therapy, 20 Maori and Pacific participants, aged 16 – 65 years, with current HbA1c of greater than or equal to 64 mmol/mol will use AHCL for 12 months.
Interventions
This is a 3-month single-arm study followed by a 9-month extension phase investigating advanced hybrid closed loop (AHCL) in Maori and Pacific adults with type 1 diabetes (T1D) and suboptimal glycaemic control that have previously not been using closed loop therapy. Following baseline assessments of blinded continuous glucose monitoring (CGM) for 14 days (using Guardian sensor and transmitter CGM system), all participants will undergo a run-in period of 72 hours running as sensor augmented pump
This is a 3-month single-arm study followed by a 9-month extension phase investigating advanced hybrid closed loop (AHCL) in Maori and Pacific adults with type 1 diabetes (T1D) and suboptimal glycaemic control that have previously not been using closed loop therapy. Following baseline assessments of blinded continuous glucose monitoring (CGM) for 14 days (using Guardian sensor and transmitter CGM system), all participants will undergo a run-in period of 72 hours running as sensor augmented pump (SAP) with predictive low glucose monitoring (PLGM) to allow subjects to familiarize with the system and for control to be optimized, and will then enter into a 3-month study period of using the insulin pump in its trial settings with the SmartGuardTM feature enabled (i.e., in Auto Mode). All participants will use the AHCL system with SmartGuardTM for a further 9 months during the extension phase. While participants have the option to enable/disable SmartGuardTM during the study, the AHCL system provides optimal results in Auto Mode and therefore participants are encouraged to keep the system in Auto Mode during the study. Expected duration of participant involvement is approx. 13 months (14 days baseline assessments, 3 days run-in, 12 months intervention period). The study intervention is the Medtronic MiniMed™ 780G AHCL insulin pump running in SmartGuardTM mode. In use with the continuous glucose monitoring (CGM) component (Guardian 4 CGM system), the MiniMed™ 780G AHCL pump is capable of continuous insulin delivery at set and variable rates, and the monitoring of glucose levels via a sensor that is inserted in the interstitial fluid under the skin, including the detection of possible low or high blood glucose episodes. The pump also displays glucose values, storing this data so that it can be retrospectively analysed. The MiniMed™ AHCL insulin pump also includes the closed loop algorithm as part of the SmartGuard™ collection of features. SmartGuard™ is comprised of Manual Mode Low Management, which includes the Suspend On Low feature (suspends insulin delivery when a pre-set low sensor glucose [SG] threshold is reached), the Suspend Before Low feature (enables insulin to suspend 30 minutes before a pre-set low SG threshold is reached) and Auto Mode (hybrid closed loop) feature. The pump can also be used as a simple pump without CGM or as a SAP without use of the SmartGuard™ features. When Auto Mode is enabled, the sensor glucose values (SGVs) received by the pump from the CGM system will be used to automatically calculate the required insulin dose. It will then deliver insulin to the patient, at five-minute intervals, to achieve glycaemic control. With the AHCL system, subjects must still deliver bolus insulin for meals. In addition, the setting for active insulin must be programmed. Basal rates are set for periods of Manual Mode (open loop) therapy. When Auto Mode is not enabled, the user may use the Smart Guard™ Low Management features. Here, basal rate delivery will be suspended either when the SG has reached a programmed low threshold (Suspend on Low) or before the SGV has reached the programmed low threshold (Suspend before Low). Participants will receive face-to-face education at the study site by trained study staff (research nurses with diabetes knowledge who are insulin pump education specialists) based on the manufacturer's user guides. The initial educational session will take approximately 5-6 hours, including the device set-up of the pump. Participants’ pump data will be automatically uploaded to CareLinkTM through the MiniMed™ Mobile phone app, which will be installed on participants’ phones and is connected with the pump via Bluetooth. The app uploads data every 24 hours into the cloud, where study staff can review the data and give feedback to refine pump settings if necessary. These refinements are personalised based on the participant’s uploaded data and will happen after each review of the uploaded pump data. Remote reviews will happen daily for 7 days after initiation of AHCL, then weekly for 6 weeks, then monthly until the end of study. Personalised pump setting changes/refinements can be insulin basal rates, active insulin time, and insulin-to-carbohydrate-ratios, if required, and will be verified by the investigative staff by way of electronic review of the pump upload with the new settings.
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
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults of Maori or Pacific ethnicity, any gender, aged 16 – 65 years inclusive on day of consent. 2. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1. 3. Current HbA1c level of greater than or equal to 8.0% (64 mmol/mol). 4. Minimum daily insulin requirement (total daily dose [TDD]) 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. Previous use of automated insulin delivery technology prior to baseline visit. 2. Previous significant adverse event at investigator discretion that precludes the participant safely using advanced diabetes technology/sensors e.g., unable to wear glucose sensors due to prior cutaneous adverse events. 3. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit. 4. Current use of Metformin, SGLT-2 or GLP-1 medications. 5. History or current evidence of severe psychiatric disorder, uncontrolled seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), or severe visual impairment that in the opinion of the Investigator would limit study involvement or be a safety issue. 6. Known moderate to severe diabetic retinopathy. 7. If participant is of child-bearing potential, 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 pre-existing medical 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