None listed
Conditions
Brief summary
The primary objective of this single arm longitudinal study is to explore the effectiveness of an advanced hybrid closed loop (AHCL) system among youth (previously using conventional injectable insulin therapy) with type 1 diabetes and a history of high-risk glycaemic control over 12 months in a real world setting. Further outcomes will explore psychological assessments and sleep quality. 20 volunteers aged 13-25 years with type 1 diabetes using conventional injection therapy and with high-risk glycaemic control will take part in the study. After baseline assessments and a run-in period, the subjects will then undergo a 12-month period of using the insulin pump in its trial settings. The new insulin delivery method being tested in all patients in this study is the Medtronic MiniMed AHCL system running in Auto mode. This is followed by 1 12-month extension phase. Expected duration of subject participation is 25 months (12 months + 17 days baseline assessments and run-in + 12 months extension). The study will be conducted at study sites in Otago and Canterbury.
Interventions
This is a single arm longitudinal study investigating advanced hybrid closed loop (AHCL) in youth with high-risk glycaemic control that have previously been using injectable insulin therapy. Following baseline assessments of blinded continuous glucose monitoring (CGM) for 14 days and 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 optimised, all subjects will th
This is a single arm longitudinal study investigating advanced hybrid closed loop (AHCL) in youth with high-risk glycaemic control that have previously been using injectable insulin therapy. Following baseline assessments of blinded continuous glucose monitoring (CGM) for 14 days and 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 optimised, all subjects will then enter into a 12-month study period of using the insulin pump in its trial settings in Auto mode. The initial 12-month study period is followed by a 12-month study extension where participants will switch from the study insulin pump to a Government-funded insulin pump (MiniMedTM AHCL insulin pump). The CGM devices (Guardian 4 sensor/transmitter system), which is currently not funded in Aotearoa New Zealand, will be provided to participants during the study extension. The treatment period for this single arm study is 24 months in total. Expected duration of subject participation is 25 months (14 days baseline assessments + 3 days run-in + 12 months treatment period + 12 months extension). The single arm study intervention is the Medtronic MiniMed™ 780G AHCL insulin pump running in AHCL mode. In use with the continuous glucose monitoring (CGM) components (Medtronic’s newest generation Guardian 4 Sensor and Guardian 4 transmitter), 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 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 CareLink through the MiniMed™ Clinical 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 the study. Personalised pump setting changes/refinements can be insulin basal rates 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
13 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 13 – 25 years inclusive. 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 8.5% (69mmol/mol). 4. Not on insulin pump therapy prior to trial. 5. Minimum daily insulin requirement of greater than or equal to 0.5 units of insulin/kg/day. 6. Willing and able to adhere to the study protocol. 7. Access to the internet and a computer system that meets requirements for uploading the study pump.
Exclusion criteria
1. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted). 2. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit. 3. Current use of SGLT-2 or GLP-1 medications. 4. Use of Hydroxyurea. 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