Type 1 Diabetes Clinical Trial
Official title:
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Verified date | December 2022 |
Source | Tandem Diabetes Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Barbara Davis Center | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
Tandem Diabetes Care, Inc. |
United States,
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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