None listed
Conditions
Brief summary
Automated insulin delivery can assist in achieving the metabolic goals of people living with type 1 diabetes while at the same time reducing the heavy intellectual and psychological burden of care. The Medtronic 780G is a second generation closed loop (artificial pancreas) system incorporating several enhancements to the currently commercially available 670G hybrid closed loop (HCL) system. Modifications include an advanced hybrid closed loop (AHCL) algorithm with adjustable glucose targets, automated correction boluses, software modifications allowing greater persistence in closed loop with fewer alarms in conjunction with smartphone connectivity. The initial pivotal trials of the 780G have demonstrated promising clinical and safety outcomes. The success of these automated devices moving forward hinge upon their ease of use and ability to reduce and relieve the burden of living with type 1 diabetes. The Melbourne cohort of twenty-two participants with type 1 diabetes using pumps with the AHCL algorithm include individuals that were involved in early feasibility studies, and some have had over two years of experience with the same AHCL algorithm used in 780G. They are currently enrolled in an extension study (ACTRN12620000687998) with their glucose levels managed by the MiniMed™ AHCL system (Medtronic, Northridge, CA), consisting of a MiniMedTM 600 series insulin pump with the AHCL algorithm in conjunction with a Medtronic GuardianTM Sensor 3. The system utilizes RF connectivity requiring initiation and implementation of data upload by the user. The sensor configuration requires calibration at least twice daily using a capillary blood glucose reading using a blood glucose meter. The 700 series Medtronic pumps utilize blue-tooth connectivity transmitting insulin delivery and glucose data seamlessly to the cloud and there is no requirement for the user to implement download of the pumps data. Also, very recently, further technical advances including a seven-day extended wear infusion set and an improved sensor form factor reducing intrusiveness and the requirement for calibration fingersticks have the potential to improve the experience of those using Closed Loop Technology. Aim: To determine feasibility and acceptance of the Next Generation Medtronic HCL System (780G; Synergy Glucose Sensor; and Extended wear infusion set)
Interventions
The purpose of this research study is determine feasibility and acceptance of the Next Generation Medtronic Hybrid Closed-Loop (HCL) System, including the 780G insulin pump, Synergy Glucose Sensor and extended wear infusion set (EWIS). The study will retrospectively benchmark the feasibility and acceptance of the Next-generation 780g system against participants’ prior HCL systems (Medtronic 670 Version 4.0; Guardian 3 sensor; commercially available three-day infusion set).
Participation in this
The purpose of this research study is determine feasibility and acceptance of the Next Generation Medtronic Hybrid Closed-Loop (HCL) System, including the 780G insulin pump, Synergy Glucose Sensor and extended wear infusion set (EWIS). The study will retrospectively benchmark the feasibility and acceptance of the Next-generation 780g system against participants’ prior HCL systems (Medtronic 670 Version 4.0; Guardian 3 sensor; commercially available three-day infusion set). Participation in this research study will occur over approximately 24 weeks. Twenty-two participants currently enrolled in a previous HCL study (ACTRN12620000687998) will be invited to participate. To participate in this project, participants will need to be over 18 years of age, have been diagnosed with type 1 diabetes, and be currently using an insulin pump and have experience with continuous glucose monitoring devices. All are currently using the Medtronic 670G V4.0 insulin pump with Guardian 3 CGM and a standard insulin infusion set. Participants will be required to attend the clinical trials centre at St Vincent’s Hospital, Melbourne on three occasions. The first occasion will involve a physical exam and medical history, answering a short questionnaire (administered by a study investigator or study nurse trained in its delivery), as well as collection of a blood sample for HbA1c. Participants will be provided with and educated regarding the use of the new study devices (Medtronic 780G system). Education will be based on new materials specifically designed by Medtronic for this HCL system. The exact glucose sensor (Guardian 3 or 4) and insulin infusion set (regular or extended wear) will be determined by the most advanced commercially available at the time of the beginning of the study. Participants will use these devices for the 12 week duration of Stage 1 of the study, during which they will go about their usual activities. They will enter data onto a smartphone application (KeyLead Health platform) regarding time spent uploading their pump data, time spent changing their glucose sensor, time spent changing their insulin set, insulin set failures, and sensor failures. After this 12-week period, participants will return to the clinical trials centre for the second occasion to answer another questionnaire and have another blood sample taken for HbA1c. Participants will return their study devices and be provided with and educated regarding the use of the new study devices (Medtronic 780G, an extended wear infusion set and Synergy sensor). Participants will use these devices for the 12 week duration of Stage 2 of the study, during which they will go about their usual activities. Participants will continue using the KeyLead Health platform to enter data as in Stage 1. The final visit to the clinical trials centre will occur after Stage 2 and will involve the return of the study devices and another blood sample for HbA1c, and completion of another study questionnaire. Following this visit participants will return to their usual mode of insulin delivery and will exit the study.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years; T1D of >1 year duration; stable on insulin pump therapy for >3 months; proficient in carbohydrate counting; continuous glucose monitoring (CGM) sensor experience; HbA1c <10.0%. Participants must have enrolled in a previously registered study in order to participate in this study (ACTRN12620000687998).
Exclusion criteria
Pregnancy; eGFR<40; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; major medical or psychiatric illness.
Outcome results
None listed