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Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT05204134•Tandem Diabetes Care, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+3 more criteria

Locations (1)

Barbara Davis Center

Aurora, Colorado, United States

Key Dates

Start Date

March 24, 2022

Primary Completion Date

September 9, 2022

Completion Date

September 29, 2022

Last Updated

April 5, 2024

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Dysautonomia in Children With Type 1 Diabetes

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Lipoprotein Kinetics in T1D

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery