Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000017729
Ethics application status
Approved
Date submitted
30/11/2021
Date registered
11/01/2022
Date last updated
11/01/2022
Date data sharing statement initially provided
11/01/2022
Date results provided
11/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and Acceptance of A Medtronic Next Generation Hybrid Closed Loop (Artificial Pancreas) System
Scientific title
Feasibility Study for A Medtronic Next Generation Hybrid Closed Loop System in adults with Type 1 diabetes
Secondary ID [1] 305932 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620000687998
All are currently enrolled in the study ACTRN12620000687998. Participants are using the 670G V4.0/ Guardian 3/ standard insulin infusion set HCL system. In this study, participants will transition to the Next Generation Medtronic HCL System, with the new data retrospectively benchmarked against participants’ prior HCL experience.

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 324526 0
Condition category
Condition code
Metabolic and Endocrine 321993 321993 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322327 0
Treatment: Devices
Comparator / control treatment
The interventional treatment (Next Generation Medtronic HCL System) will be retrospectively benchmarked against the control treatment (participants’ prior HCL systems [Medtronic 670 Version 4.0; Guardian 3 sensor; commercially available three-day infusion set]).
Restrospective data will be gathered for the 12-weeks preceding the enrollment into this trial, and will be obtained from the participants/their devices at the screening visit.
Control group
Historical

Outcomes
Primary outcome [1] 329751 0
Treatment Satisfaction measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Change Score.
Timepoint [1] 329751 0
Treatment satisfaction will be determined at baseline (previous 12-weeks of original HCL treatment), after Stage 1 completion (12 weeks post-enrolment; most recent commercially available HCL treatment) and after Stage 2 completion (24 weeks post-enrolment; Investigational HCL treatment).
Secondary outcome [1] 403660 0
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each 12-week period, including:
CGM % time spent in target glycaemia ([a] 3.9-10.0 mmol/L and [b] 3.9-7.8 mmol/L); hyperglycaemia (>10.0 mmol/L, >13.9mmol/L); hypoglycaemia (<3.9 mmol/L, <3.5 mmol/L, <3.0 mmol/L, and <2.8 mmol/L).
Timepoint [1] 403660 0
Assessed daily from enrolment up to 12 weeks (Stage 1; most recent commercially available HCL treatment), then daily from 12 weeks to 24 weeks post-enrolment (Stage 2; Investigational HCL treatment).
Secondary outcome [2] 404360 0
HbA1c will be determined using a serum assay at baseline and at the end of the 12-week intervention.
Timepoint [2] 404360 0
HbA1c will be determined at the end of each 12 week stage - i.e. at 12 weeks and 24 weeks post-commencement of study

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
20/12/2021
Date of last participant enrolment
Anticipated
Actual
24/12/2021
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310273 0
Commercial sector/Industry
Name [1] 310273 0
Medtronic
Country [1] 310273 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
35 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 311381 0
None
Name [1] 311381 0
Address [1] 311381 0
Country [1] 311381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309944 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 309944 0
Ethics committee country [1] 309944 0
Australia
Date submitted for ethics approval [1] 309944 0
Approval date [1] 309944 0
24/11/2021
Ethics approval number [1] 309944 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115934 0
Prof David O'Neal
Address 115934 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 115934 0
Australia
Phone 115934 0
+61 3 92882012
Fax 115934 0
Email 115934 0
dno@unimelb.edu.au
Contact person for public queries
Name 115935 0
Dale Morrison
Address 115935 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 115935 0
Australia
Phone 115935 0
+61413137853
Fax 115935 0
Email 115935 0
dale.morrison@unimelb.edu.au
Contact person for scientific queries
Name 115936 0
Dale Morrison
Address 115936 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 115936 0
Australia
Phone 115936 0
+61413137853
Fax 115936 0
Email 115936 0
dale.morrison@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.