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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05204134
Other study ID # TP-0009348
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2022
Est. completion date September 29, 2022

Study information

Verified date December 2022
Source Tandem Diabetes Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.


Description:

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 29, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult subjects = age 18 years - Clinical diagnosis of type 1 diabetes for at least one year - Using a basal/bolus regimen by injection (MDI therapy) - Total daily dose =10 units/day - Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump. - A1c = 7.5% and = 11% at screening - Not pregnant or planning a pregnancy during the time period of the study. - Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) - Willingness to follow study procedures and a signed informed consent form Exclusion Criteria: - Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months - Two or more episodes of diabetic ketoacidosis in the past 6 months - Inpatient psychiatric treatment in the past 6 months - 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 - Significant chronic kidney disease or hemodialysis - Significant liver disease - History of adrenal insufficiency - Hypothyroidism or hyperthyroidism that is not appropriately treated - Other chronic disease/condition determined by investigator to interfere with participation in the study - Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study - Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump - Subject is pregnant or lactating or intending to become pregnant before or during participation in this study - Investigator judgement that subject would not be able to complete the trial

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Locations

Country Name City State
United States Barbara Davis Center Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severe Hypoglycemic Events Number of severe hypoglycemic events (needing assistance) compared to expected incidence 13 weeks
Secondary Percent of time 70-180 mg/dL CGM percent time 70-180 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Percent of time <54 mg/dL CGM percent time <54 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Percent of time <70 mg/dL CGM percent time <70 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Percent of time >180 mg/dL CGM percent time >180 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Percent of time >250 mg/dL CGM percent time >250 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Percent of time 70-140 mg/dL CGM percent time 70-140 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Postprandial glycemic peak mg/dL Peak CGM glucose after meals, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary 4-Hour post meal glucose AUC 4-Hour post meal glucose AUC, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary Sensor glucose median and interquartile range mg/dL Sensor glucose median and interquartile range , cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection 15 weeks
Secondary CGM Metrics by time of day Calculate all CGM metrics listed above for: all 24 hours of the day, daytime only, and nighttime only 15 weeks
Secondary Serious Adverse Events Number of Serious Adverse Events 15 weeks
Secondary Adverse Device Effects Number of Adverse Device Effects 15 weeks
Secondary Change in total daily insulin use, basal and bolus Changes in units/day insulin use, for both basal and bolus insulin 13 weeks
Secondary Physician overrides/physician initiated changes in pump settings Number of physician overrides/physician initiated changes in pump settings 13 weeks
Secondary Patient Reported Outcomes Score on Diabetes Impact and Device Satisfaction Scale 13 weeks
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