Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

Type 1 Diabetes Clinical Trial

Official title:

Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204134
• Other study ID #: TP-0009348
• Status: Completed
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: September 29, 2022

Study information

• Verified date: March 2024
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• 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: 33
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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, 

References & Publications (1)

Shah VN, Akturk HK, Trahan A, Piquette N, Wheatcroft A, Schertz E, Carmello K, Mueller L, White K, Fu L, Sassan-Katchalski R, Messer LH, Habif S, Constantin A, Pinsker JE. Safety and Feasibility Evaluation of Automated User Profile Settings Initialization — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Hypoglycemic Events	Number of Severe Hypoglycemic Events (with altered mental status)	15 weeks
Primary	Diabetic Ketoacidosis Events	Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)	15 weeks
Secondary	Percent Time < 54 mg/dL, Overall	CGM percent time < 54 mg/dL, Overall Study Participation	15 weeks
Secondary	Percent Time < 54 mg/dL, Daytime Outcomes	CGM percent time < 54 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Secondary	Percent Time < 54 mg/dL, Overnight Outcomes	CGM percent time < 54 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Secondary	Percent Time < 70 mg/dL, Overall	CGM percent time < 70 mg/dL, Overall Study Participation	15 weeks
Secondary	Percent Time < 70 mg/dL, Daytime Outcomes	CGM percent time < 70 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Secondary	Percent Time < 70 mg/dL, Overnight Outcomes	CGM percent time < 70 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Secondary	Percent of Time 70-140 mg/dL, Overall	CGM percent time 70-140 mg/dL, Overall Study Participation	15 weeks
Secondary	Percent of Time 70-140 mg/dL, Daytime Outcomes	CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Secondary	Percent of Time 70-140 mg/dL, Overnight Outcomes	CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Secondary	Percent of Time 70-180 mg/dL, Overall	CGM percent time 70-180 mg/dL, Overall Study Participation	15 weeks
Secondary	Percent of Time 70-180 mg/dL, Daytime Outcomes	CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Secondary	Percent of Time 70-180 mg/dL, Overnight Outcomes	CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Secondary	Percent Time > 180 mg/dL, Overall	CGM percent time > 180 mg/dL, Overall Study Participation	15 weeks
Secondary	Percent Time > 180 mg/dL, Daytime Outcomes	CGM percent time > 180 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Secondary	Percent Time > 180 mg/dL, Overnight Outcomes	CGM percent time > 180 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Secondary	Percent Time > 250 mg/dL, Overall	CGM percent time > 250 mg/dL, Overall Study Participation	15 weeks
Secondary	Percent Time > 250 mg/dL, Daytime Outcomes	CGM percent time > 250 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Secondary	Percent Time > 250 mg/dL, Overnight Outcomes	CGM percent time > 250 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Secondary	Median Sensor Glucose	CGM-measured median glucose (mg/dL)	15 weeks
Secondary	Total Daily Insulin Use	Total Daily Insulin Use (Units/Day)	15 weeks
Secondary	Total Daily Bolus Insulin Use	Total Daily Bolus Insulin Use (units/day)	15 weeks
Secondary	Total Daily Basal Insulin Use	Total Daily Basal Insulin Use (units/day)	15 weeks
Secondary	Physician Overrides/Physician Initiated Changes in Pump Settings	Number of physician overrides/physician initiated changes in pump settings during the entire study.	13 weeks
Secondary	Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion	The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings	13 weeks
Secondary	Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion	The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings	13 weeks