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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

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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Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients (inRange)
Eligibility
Sex / Gender

All

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

Primary Objective:

To demonstrate the noninferiority of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL on glycemic control and variability in participants with diabetes mellitus

Secondary Objective:

To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring (CGM)

To evaluate the safety of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL

Sponsor

Sanofi

Estimated Primary Completion Date

September 2020

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Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Insulin-Requiring Diabetes
Eligibility
Sex / Gender

All

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

This study is a multi-center, non-randomized, prospective single arm study with insulin-requiring patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM).

Sponsor

Medtronic Diabetes

Estimated Primary Completion Date

April 2020

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Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
Eligibility
Sex / Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin-requiring diabetes,18-75 years of age.

Sponsor

Medtronic Diabetes

Estimated Primary Completion Date

N/A

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Type 1 - Pediatrics

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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Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)
Eligibility
Sex / Gender

All

Ages

8 Years to 17 Years

Accepts Healthy Volunteers

No

About

*Additional Link* https://theprotectstudy.com/home/

Primary Objective:

The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

Sponsor

Provention Bio, Inc.

Estimated Primary Completion Date

May 2022

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Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
Eligibility
Sex / Gender

All

Ages

7 Years to 75 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.

Sponsor

Medtronic Diabetes

Estimated Primary Completion Date

January 31, 2020

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Type 2 Diabetes

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes (FOCUS)
Eligibility
Sex / Gender

All

Ages

18 Years and Older (Adult, Older Adult)

Accepts Healthy Volunteers

No

About
Brief Summary:

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines – which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

Sponsor

Novo Nordisk A/S

Estimated Primary Completion Date

February 5, 2025

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Research Participant Application

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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:

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

Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02
Eligibility
Sex / Gender

All

Ages

18 Years and Older (Adult, Older Adult)

Accepts Healthy Volunteers

No

About
Brief Summary:

This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

Sponsor

Allergan

Estimated Primary Completion Date

January 18, 2020

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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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General Endocrine

A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants (ARCH)
Eligibility
Sex / Gender

All

Ages

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers

No

About
Brief Summary:

This study will evaluate the safe and effective dose conversion from synthetic T4 therapy to Armour Thyroid therapy in participants who are euthyroid on a stable dose of synthetic T4.

Sponsor

Allergan

Estimated Primary Completion Date

July 28, 2021

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A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome (GRACE)
Eligibility
Sex / Gender

All

Ages

18 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers

No

About
Brief Summary:

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the safety and efficacy of relacorilant in patients with endogenous Cushing syndrome and concurrent 1) Type 2 diabetes mellitus/impaired glucose tolerance and/or 2) uncontrolled hypertension

Sponsor

Corcept Therapeutics

Estimated Primary Completion Date

December 2020

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