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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
Sponsored by
Tandem Diabetes Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Davis Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates

Arm Description

After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.

Outcomes

Primary Outcome Measures

Severe Hypoglycemic Events
Number of severe hypoglycemic events (needing assistance) compared to expected incidence

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
CGM Metrics by time of day
Calculate all CGM metrics listed above for: all 24 hours of the day, daytime only, and nighttime only
Serious Adverse Events
Number of Serious Adverse Events
Adverse Device Effects
Number of Adverse Device Effects
Change in total daily insulin use, basal and bolus
Changes in units/day insulin use, for both basal and bolus insulin
Physician overrides/physician initiated changes in pump settings
Number of physician overrides/physician initiated changes in pump settings
Patient Reported Outcomes
Score on Diabetes Impact and Device Satisfaction Scale

Full Information

First Posted
January 10, 2022
Last Updated
December 21, 2022
Sponsor
Tandem Diabetes Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05204134
Brief Title
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Official Title
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tandem Diabetes Care, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates
Arm Type
Experimental
Arm Description
After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.
Intervention Type
Device
Intervention Name(s)
Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severe Hypoglycemic Events
Description
Number of severe hypoglycemic events (needing assistance) compared to expected incidence
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Percent of time 70-180 mg/dL
Description
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
Time Frame
15 weeks
Title
Percent of time <54 mg/dL
Description
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
Time Frame
15 weeks
Title
Percent of time <70 mg/dL
Description
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
Time Frame
15 weeks
Title
Percent of time >180 mg/dL
Description
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
Time Frame
15 weeks
Title
Percent of time >250 mg/dL
Description
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
Time Frame
15 weeks
Title
Percent of time 70-140 mg/dL
Description
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
Time Frame
15 weeks
Title
Postprandial glycemic peak mg/dL
Description
Peak CGM glucose after meals, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection
Time Frame
15 weeks
Title
4-Hour post meal glucose AUC
Description
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
Time Frame
15 weeks
Title
Sensor glucose median and interquartile range mg/dL
Description
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
Time Frame
15 weeks
Title
CGM Metrics by time of day
Description
Calculate all CGM metrics listed above for: all 24 hours of the day, daytime only, and nighttime only
Time Frame
15 weeks
Title
Serious Adverse Events
Description
Number of Serious Adverse Events
Time Frame
15 weeks
Title
Adverse Device Effects
Description
Number of Adverse Device Effects
Time Frame
15 weeks
Title
Change in total daily insulin use, basal and bolus
Description
Changes in units/day insulin use, for both basal and bolus insulin
Time Frame
13 weeks
Title
Physician overrides/physician initiated changes in pump settings
Description
Number of physician overrides/physician initiated changes in pump settings
Time Frame
13 weeks
Title
Patient Reported Outcomes
Description
Score on Diabetes Impact and Device Satisfaction Scale
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan E Pinsker, MD
Organizational Affiliation
Tandem Diabetes Care, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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