Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403502
• Other study ID #: TP-0009650
• Status: Completed
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: August 2023
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.

Description:

This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80 years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump. After a run-in period, participants will use the study pump with Control-IQ technology 1.5 and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be enrolled so at least 160 complete the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 6 to <81 years

2. Diagnosis of type 1 diabetes for at least 1 year

3. Currently using Control-IQ technology for at least 3 months, with CGM data recorded indicative of system use (active closed loop) for at least 85% of the possible time in 14 days prior to enrollment

4. Total daily insulin dose (TDD) at least 2 U/day

5. HbA1c < 10.5%

6. Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.

7. For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.

8. If >18 years old, participant has someone who lives within 30 minutes of them who is willing to be contacted if the study team can't reach the participant in case of a suspected medical emergency.

9. Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF) and assent, if applicable; and has agreed to

follow all study procedures, including:

1. suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use

2. switching to or continuing to use Humalog during the lead-in period

3. switching to Lyumjev for the main study period.

4. willing and able to perform the study exercise and meal challenges.

10. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.

11. Participant and/or parent/legal guardian have the ability to read and understand English

Exclusion Criteria:

1. More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months

2. More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months

3. Inpatient psychiatric treatment in the past 6 months

4. History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.

5. For Female: Currently pregnant or planning to become pregnant during the time period of study participation

1. A negative pregnancy test will be required for all females of child-bearing potential (menarchal)

2. Counseling on appropriate birth control options will be provided to females with child-bearing potential in the event the participant does not have an acceptable plan.

6. Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator

7. 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).

8. Hemophilia or any other bleeding disorder

9. Hemoglobinopathy

10. History of heart, liver, lung or kidney disease determined by investigator to interfere with the study

11. History of allergic reaction to Humalog or Lyumjev

12. Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study

13. Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (>450 ms) (Screening ECG only required for participants age > 50 years, duration of diabetes > 20 years, or history of coronary artery disease)

14. Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis

15. History of adrenal insufficiency

16. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated

17. History of gastroparesis

18. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk

19. Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation

20. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Eli Lilly and Co., or TypeZero Technologies, LLC, 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• t:slim X2 insulin pump with Control-IQ technology 1.5
t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Evanston	Illinois
United States	University of Florida	Gainesville	Florida
United States	Indiana University / Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Children's Hospital Orange County	Orange	California
United States	Stanford University	Palo Alto	California
United States	Diabetes & Glandular Disease (DGD)	San Antonio	Texas
United States	University of South Florida Diabetes Center	Tampa	Florida
United States	Iowa Diabetes and Endocrinology Research Center (IDERC)	West Des Moines	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.	Eli Lilly and Company, Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postprandial incremental area under the glucose curve	CGM postprandial incremental area under the glucose curve (4 hr)	4 hours
Other	Peak postprandial glucose	Peak postprandial glucose (mg/dL)	4 hours
Other	Time in range - overall and postprandial 70-180 mg/dL	CGM time in range 70-180 mg/dL overall and postprandial	3 months
Other	Time in range - overall and postprandial >180 mg/dL	CGM time in range >180 mg/dL overall and postprandial	3 months
Other	Time in range - overall and postprandial >250 mg/dL	CGM time in range >250 mg/dL overall and postprandial	3 months
Other	Times in range - overall and postprandial 70-140 mg/dL	CGM time in range 70-140 mg/dL overall and postprandial	3 months
Other	Mean glucose	Mean CGM glucose mg/dL	3 months
Other	Rate of hyperglycemia events	Rate of hyperglycemia events, defined as 90 or more minutes >300 mg/dL within 120 minutes	3 months
Other	Overall variability (Coefficient of Variation and Standard Deviation)	CGM overall variability as measured by Coefficient of Variation and Standard Deviation (mg/dL)	3 months
Other	HbA1c change from baseline	Change in HbA1c (%) from baseline to 3 months	3 months
Other	CGM metrics for time in range by time of day	CGM metrics for time in range for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
Other	CGM metrics for time in hypoglycemia by time of day	CGM metrics for time in hypoglycemia for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
Other	CGM metrics for time in hyperglycemia by time of day	CGM metrics for time in hyperglycemia for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
Other	CGM metrics for glucose variability by time of day	CGM metrics for glucose variability for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
Other	Patient Reported Outcomes: TRIM-D	Patient Reported Outcomes on the TRIM-D scale, comparing baseline to 3 months	3 months
Other	Patient Reported Outcomes: TRIM-DD	Patient Reported Outcomes on the TRIM-DD scale, comparing baseline to 3 months	3 months
Other	Patient Reported Outcomes: ITSQ	Patient Reported Outcomes on the ITSQ scale, comparing baseline to 3 months	3 months
Primary	Severe hypoglycemia	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry	3 months
Primary	Diabetic ketoacidosis	Number of diabetic ketoacidosis events	3 months
Primary	Unanticipated adverse device effects	Number of unanticipated adverse device effects (UADE) events	3 months
Primary	Other serious adverse events	Number of other serious adverse events	3 months
Primary	Adverse drug reactions	Number of adverse drug reactions	3 months
Secondary	All reportable adverse events	Number of reportable adverse events during the course of the study	3 months
Secondary	CGM hypoglycemia outcomes: Overall % time <54 mg/dL	CGM overall percent time < 54 mg/dL	3 months
Secondary	CGM hypoglycemia outcomes: Postprandial % time <54 mg/dL	CGM postprandial percent time < 54 mg/dL	3 months
Secondary	CGM hypoglycemia outcomes: Overall % time <70 mg/dL	CGM overall percent time < 70 mg/dL	3 months
Secondary	CGM hypoglycemia outcomes: Postprandial % time <70 mg/dL	CGM postprandial percent time < 70 mg/dL	3 months
Secondary	CGM hypoglycemia outcomes: Rate of hypoglycemia events	Rate of hypoglycemia events defined as 15 or more consecutive minutes <54 mg/dL	3 months