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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

Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
Eligibility
Sex / Gender

All

Ages

21 years to 64 years

Accepts Healthy Volunteers

No

About
Summary:

This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects’ counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.

Sponsor

Xeris Pharmaceuticals

Estimated Primary Completion Date

July 31, 2018

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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

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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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 Glucose Monitoring in T2D Basal Insulin Users: The MOBILE Study
Eligibility
Sex / Gender

All

Ages

30 Years and Older (Adult, Older Adult)

Accepts Healthy Volunteers

No

About
Primary Objective:

A study to compare the glycemic and quality of life benefits of diabetes management using Dexcom G6 continuous glucose monitoring (CGM) or self-monitored blood glucose (SMBG) made by study participants and their primary care physicians. Decisions will be based on insights from real-time use and retrospective insights, determined during remote visits.

Sponsor

DexCom, Inc.

Estimated Primary Completion Date

May 2021

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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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Obesity

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects with Overweight or Obesity and Type 2 Diabetes
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 change in the participant’s body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking “dummy” medicine.

Sponsor

Novo Nordisk A/S

Estimated Primary Completion Date

May 16, 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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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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