Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study
Diabetes MellitusType 1The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.
The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study
Type1 Diabetes MellitusThe iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas. The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation. This is a multicenter study of pediatric participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.
The Insulin-Only Bionic Pancreas Pivotal Trial
Diabetes MellitusType 1 Diabetes2 moreThis multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP System or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT. There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for ~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).
Feasibility Study of Family Teamwork Peer-Delivery
Type 1 DiabetesThe purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D. A randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists.
Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
Type 1 DiabetesThis prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
DiabetesDiabetes Mellitus1 moreThis trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System
Type 1 DiabetesThe purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin. The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.
A Study in Adults With Type 1 Diabetes
Diabetes MellitusType 1The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus...
Type 1 Diabetes MellitusAlpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its anti-inflammatory properties. AAT is an acute stress reactant protein that increases during inflammation. In T1DM inflammation serves a major role in disease progression.
Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
DepressionType 1 DiabetesThis study is a pilot behavioral intervention trial, designed to initially examine cognitive behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression and poorly controlled type 1 diabetes.