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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

Feasibility Study with Personalized Closed Loop (PCL)
Eligibility
Sex / Gender

All

Ages

2-80

Accepts Healthy Volunteers

No

About
Primary Objective:

The objective of the study is to collect device data to assist in the development of a Personalized Closed Loop (PCL) system.

Sponsor

Medtronic

Estimated Primary Completion Date

September 30, 202

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Use of the Guardian™ Connect system with Smart Connected Devices
Eligibility
Sex / Gender

All

Ages

2-80

Accepts Healthy Volunteers

No

About
Primary Objective:

The primary objective of this feasibility study is to collect data to be used for development of Medtronic Diabetes devices and products.

Sponsor

Medtronic

Estimated Primary Completion Date

April 30, 2022

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Next Generation Sensor (NGS) Research Study
Eligibility
Sex / Gender

All

Ages

2-80

Accepts Healthy Volunteers

No

About
Brief Summary:

The primary objective of this feasibility study is to collect data to be used for development of Medtronic Diabetes devices and products.

Sponsor

Medtronic

 

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A Study of Oral Ladarixin in New-onset Type 1 Diabetes and a Low Residual β-cell Function
Eligibility
Sex / Gender

All

Ages

14-45

Accepts Healthy Volunteers

No

About
Primary Objective:

The objective of this clinical trial is to assess whether ladarixin treatment is effective in preserving b-cell function and delaying the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.

Sponsor

Dompé Farmaceutici

Estimated Primary Completion Date

June 2023

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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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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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