Examining The Role of CGM in T2DM

NCT01614262 | Completed

• 1 other identifier: 12-0899
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic control can be achieved through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical outcomes in patients with T2DM treated with OADs is warranted.

Conditions

DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)

Outcome Measures

Primary Outcomes (1)

• change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring

  baseline and day 187

Secondary Outcomes (3)

• change in fasting plasma glucose between two groups

  baseline and day 187

• comparison of change of the area under the curve for CGM results for both treatment arms

  baseline and day 187

• quality of life data evaluation

  baseline and day 187

Study Arms (2)

Continuous Glucose Monitoring

EXPERIMENTAL

The Continuous Glucose Monitoring (CGM) arm will receive care based upon results from there CGM data; treatment decisions are based on algorithm and CGM data

Other: Continuous Glucose Monitoring with treatment algorithm

Self Monitoring Blood Glucose

ACTIVE COMPARATOR

Subjects in the Self Monitoring Blood Glucose group will have treatment decisions based on self monitored blood glucose values and not CGM values, per current standard of care.

Other: Continuous Glucose Monitoring with treatment algorithm

Interventions

Continuous Glucose Monitoring with treatment algorithm OTHER

those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.

Continuous Glucose Monitoring; Self Monitoring Blood Glucose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject is eligible for the study if all of the following criteria are met:
• Provide written informed consent prior to enrollment
• Is male or female between 18-70 years old
• Has been treated by the Principal Investigator or referring physician in the same practice.
• Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic medications, on a stable dose for 90 days prior to screening.
• Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.
• Currently performs self-monitoring blood glucose checks at least 3 times per week.
• Ability to adhere to protocol requirements.

You may not qualify if:

• \. Has Type 1 Diabetes or Gestational Diabetes
• Is pregnant or planning to become pregnant during the course of the study.
• Current use of any insulin or history of insulin use in the last 6 months.
• An acute coronary or cerebrovascular event in the previous 3 months.
• Any planned surgery during the course of the study.
• Current continuous renal replacement therapy.
• BMI ≥ 45 kg/m\^2
• Current oral or injectable steroid use.
• Any previous history Continuous Glucose Monitoring use by any device or manufacturer.
• Has a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Medtronic: collaborator
• Atlanta Diabetes Associates: collaborator
• UNC Coordinating Center: collaborator

Study Sites (2)

Atlanta Diabetes Assoicates

Atlanta, Georgia, 30309, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• John B Buse, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 19, 2017

Record last verified: 2015-07

Locations

US (2)