None listed
Conditions
Brief summary
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 Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting for 3 days/nights.
Interventions
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 (CG
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.
Sponsors
University of Otago, Christchurch.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed