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Research

Atlanta Diabetes Associates Clinical Research

Our mission is to provide patients and sponsors with the highest quality of clinical research available today. We strive to deliver efficient and accurate research data and strictly adhere to protocol guidelines, while maintaining patient safety as our number one priority.

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Currently Enrolling

Type 1 Diabetes

Mylan Insulin Glargine Study
Eligibility
Sex / Gender

All

Ages

18 years to 65 years

Accepts Healthy Volunteers

No

About
Primary Objective:

To test whether MYL-1501D product from Process VI once daily is non-inferior to MYL-1501D product from Process V once daily based on change in HbA1c when administered in combination with mealtime insulin lispro.

Sponsor

Mylan Inc.

Estimated Primary Completion Date

December 2018

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Continuous Monitoring and Control of Hypoglycemia (COACH)
Eligibility
Sex / Gender

All

Ages

2 years and older

Accepts Healthy Volunteers

No

About
Primary Objective:

Change in average number of hypoglycemic events per patient between CGM use compared to BGM use

Sponsor

DexCom, Inc.

Estimated Primary Completion Date

May 15, 2020

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Wireless Innovation for Seniors with Diabetes Mellitus (WISDM)
Eligibility
Sex / Gender

All

Ages

60 years and older

Accepts Healthy Volunteers

Yes

About
Primary Objective:

The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.

Sponsor

Jaeb Center for Health Research

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust
Juvenile Diabetes Research Foundation

Estimated Primary Completion Date

October 2019

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A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (T1GER)
Eligibility
Sex / Gender

All

Ages

6 Years to 21 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

Sponsor

Janssen Research & Development, LLC

Estimated Primary Completion Date

February 25, 2019

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Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home
Eligibility
Sex / Gender

All

Ages

7 Years to 75 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

Sponsor

Medtronic Diabetes

Estimated Primary Completion Date

August 2021

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Type 1 - Pediatrics

A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (T1GER)
Eligibility
Sex / Gender

All

Ages

6 years to 21 years

Accepts Healthy Volunteers

No

About
Primary Objective:

The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

Sponsor

Janssen Research & Development, LLC

Estimated Primary Completion Date

March 25, 2020

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Research Participant Application

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FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
Eligibility
Sex / Gender

All

Ages

4 years to 17 years

Accepts Healthy Volunteers

No

About
Summary:

This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.

Sponsor

Abbott Diabetes Care

Estimated Primary Completion Date

July 2018

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Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Eligibility
Sex / Gender

All

Ages

4 Years to 17 Years

Accepts Healthy Volunteers

No

About
Primary Objective:

To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).

Sponsor

Mannkind Corporation

Estimated Primary Completion Date

July 2020

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Type 2 Diabetes

Continuous Monitoring and Control of Hypoglycemia (COACH)
Eligibility
Sex / Gender

All

Ages

2 years and older

Accepts Healthy Volunteers

No

About
Primary Objective:

Evaluate safety of non-adjunctive CGM use in CGM naive participants.

Sponsor

DexCom, Inc.

Estimated Primary Completion Date

May 15, 2020

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Diabetic Complications

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)
Eligibility
Sex / Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

About
Purpose:

The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Sponsor

Bayer

Estimated Primary Completion Date

September 29, 2019

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People Without Diabetes

Pathway to Prevention Study
Eligibility
Sex / Gender

All

Ages

1-45 years

Accepts Healthy Volunteers

Yes

Study Population

First and second/third degree relatives of individuals with type 1 diabetes.

About
Brief Summary:

The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator
  • National Center for Research Resources (NCRR)
  • Juvenile Diabetes Research Foundation
  • American Diabetes Association

 

Estimated Primary Completion Date

July 2019

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