Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000559516
Ethics application status
Approved
Date submitted
26/03/2024
Date registered
3/05/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
3/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Tandem Freedom Feasibility Trial: evaluating the Tandem Freedom system compared to a Control-IQ technology run-in phase in adults with type 1 diabetes
Scientific title
Tandem Freedom Feasibility Trial #1: evaluating the Tandem Freedom system compared to a Control-IQ technology run-in phase in adults with type 1 diabetes
Secondary ID [1] 311798 0
Nil known
Universal Trial Number (UTN)
U1111-1307-6267
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 333315 0
Condition category
Condition code
Metabolic and Endocrine 330001 330001 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use the Tandem Freedom system in a supervised hotel setting with Dexcom follow active. The Tandem Freedom system is a computer algorithm installed in the insulin pump and will be used from night 1 in the hotel until the end of the study 3 days later. Automated insulin delivery (AID) requires a continuous glucose monitoring (CGM) sensor combined with an insulin pump and an algorithm that adapts insulin delivery in real time to target normal glucose levels. The Tandem Freedom algorithm has been designed to be used without requiring meal boluses, unlike existing Control-IQ technology which requires the user to announce the carbohydrates to be consumed. Participants stay in the hotel for the full duration of the study, where a study team will also stay, including on-site nurses and a doctor with specific training in diabetes. Insulin pump data will be uploaded to assess adherence to the intervention. Participants will consume an unannounced meal while still using their Control-IQ technology at the start of the hotel stay. This meal will be selected from the menu by the participant, contain at least 50g carbohydrate, and the same meal will be eaten for lunch on days 2 and 3 of the hotel stay. The post-prandial period will be monitored for 5 hours before changing participants to the Tandem Freedom technology system. On the first day of using the Tandem Freedom system (day 2 of the hotel stay), participants will have announced meals for breakfast, lunch and dinner. On the second day of using the Tandem Freedom system (day 3 of the hotel stay), participants will have unannounced meals for breakfast, lunch and dinner.
Participants will have unrestricted living for the duration of the study, they are permitted to complete any physical activity or tasks as they wish.
Intervention code [1] 328246 0
Treatment: Devices
Comparator / control treatment
Comparator is Control-IQ technology and participants will act as their own control. All study participants are existing Control-IQ users. The Control-IQ algorithm is installed on their insulin pumps and adapts insulin delivery in real time to target normal glucose levels. Insulin pump data will be used to monitor adherence.
Control group
Active

Outcomes
Primary outcome [1] 337778 0
Number of severe hypoglycaemia events (with cognitive impairment such that assistance of another individual is needed for treatment.)
Timepoint [1] 337778 0
Number of events from the Control-IQ run-in period until the completion of the Tandem Freedom hotel observed weekend period.
Primary outcome [2] 337779 0
Number of diabetic ketoacidosis events.
Timepoint [2] 337779 0
Number of events from the Control-IQ run-in period until the completion of the Tandem Freedom hotel observed weekend period.
Primary outcome [3] 338131 0
Number of unanticipated adverse device events and number of other serious device-related adverse events.
Timepoint [3] 338131 0
Number of events from the Control-IQ run-in period until the completion of the Tandem Freedom hotel observed weekend period.
Secondary outcome [1] 433294 0
All device-related adverse events. Known/possible adverse reactions include skin reactions such as rashes at the point of adhesion of CGM sensor or insulin infusion set. Infection is also possible at the point of insertion of CGM sensor or insulin infusion set. Adverse reactions/events such as these will be assessed by a medical professional and treated if required.
Timepoint [1] 433294 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [2] 433295 0
CGM hypoglycaemia outcomes (overall %time <54mg/dL(<3.0mmol/L))
Timepoint [2] 433295 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [3] 433841 0
CGM hypoglycaemia outcomes (overall %time <70mg/dL(<3.9mmol/L))
Timepoint [3] 433841 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [4] 434609 0
CGM time in range (70-180mg/dL(3.9-10.0mmol/L))
Timepoint [4] 434609 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [5] 434611 0
CGM time in range (>180mg/dL(>10.0mmol/L))
Timepoint [5] 434611 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [6] 434612 0
CGM time in range (>250mg/dL(>13.9mmol/L))
Timepoint [6] 434612 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [7] 434613 0
CGM time in range (70-140mg/dL(3.9-7.8mmol/L))
Timepoint [7] 434613 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [8] 434614 0
Mean glucose
Timepoint [8] 434614 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.
Secondary outcome [9] 434615 0
Glycaemic variability (Coefficient of variation (CV) and standard variation (SD)).
Timepoint [9] 434615 0
Continuous glucose monitoring throughout the duration of Tandem Freedom use (4 days/3 nights) as compared to Control-IQ use (7-10 days). Further stratified by recommended bolus therapy.

Eligibility
Key inclusion criteria
1. Age >=18 years old.
2. Diagnosis of type 1 diabetes for at least 1 year.
3. Current Control-IQ user for at least 3 months.
4. HbA1c<=10%, recorded in the last 3 months
5. Can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
6. Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months.
2. More than 1 episode of severe hypoglycaemia (needing assistance) in the past 6 months.
3. Inpatient psychiatric treatment in the past 6 months.
4. For female: Currently pregnant or planning to become pregnant during the time period of study participation.
5. Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
6. Hemophilia or any other bleeding disorder.
7. Hemoglobinopathy.
8. History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
9. History of allergic reaction to Humalog or Novorapid
10. Use of any medications determined by investigator to interfere with study
11. Significant chronic kidney disease (which could impact continuous glucose monitoring (CGM) accuracy in investigator’s judgment) or hemodialysis
12. Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
13. History of adrenal insufficiency
14. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
15. History of gastroparesis
16. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
17. Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
18. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary objective of the study is assessment of safety. Therefore, there are no formal statistical hypotheses associated with any of the endpoints. Outcomes will be primarily descriptive in nature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2024
Actual
29/05/2024
Date of last participant enrolment
Anticipated
24/05/2024
Actual
31/05/2024
Date of last data collection
Anticipated
14/06/2024
Actual
10/06/2024
Sample size
Target
20
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 26217 0
New Zealand
State/province [1] 26217 0
Canterbury

Funding & Sponsors
Funding source category [1] 316134 0
Commercial sector/Industry
Name [1] 316134 0
Tandem Diabetes Care, Inc.
Country [1] 316134 0
United States of America
Primary sponsor type
University
Name
University of Otago, Christchurch.
Address
Country
New Zealand
Secondary sponsor category [1] 318309 0
None
Name [1] 318309 0
Address [1] 318309 0
Country [1] 318309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314960 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314960 0
Ethics committee country [1] 314960 0
New Zealand
Date submitted for ethics approval [1] 314960 0
21/03/2024
Approval date [1] 314960 0
15/05/2024
Ethics approval number [1] 314960 0
2024 FULL 20023

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

Contacts
Principal investigator
Name 133258 0
A/Prof Martin de Bock
Address 133258 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 133258 0
New Zealand
Phone 133258 0
+64 3 372 6763
Fax 133258 0
Email 133258 0
[email protected]
Contact person for public queries
Name 133259 0
Martin de Bock
Address 133259 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 133259 0
New Zealand
Phone 133259 0
+64 3 372 6763
Fax 133259 0
Email 133259 0
[email protected]
Contact person for scientific queries
Name 133260 0
Martin de Bock
Address 133260 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 133260 0
New Zealand
Phone 133260 0
+64 3 372 6763
Fax 133260 0
Email 133260 0
[email protected]

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.