Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring

NCT01072565 | Completed

• 1 other identifier: 03914-09-C
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; A1c; Continuous Glucose Monitoring; Blood Glucose

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.

  Three, six and nine months.

Secondary Outcomes (1)

• Determine the incremental benefit of CGM for clinical decision-making.

  Three, six and nine months.

Study Arms (2)

SMBG Only

ACTIVE COMPARATOR

You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be blinded (neither you nor the study doctor will be able to see the CGM measurements until your final study visit). Only your SMBG measurements will be considered to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of less than 7%.

Other: SMBG to guide clinical decisions

SMBG and CGM

ACTIVE COMPARATOR

You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be downloaded at each study visit and will be considered along with your SMBG measurements to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of 7%.

Other: SMBG and CGM

Interventions

SMBG to guide clinical decisions OTHER

The investigator will base clinical decisions on A1c and modal day analysis of SMBG.

SMBG Only

SMBG and CGM OTHER

The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.

SMBG and CGM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 and ≤75 years of age
• Clinical diagnosis of diabetes
• Diabetes duration ≥ 1 year
• HbA1c ≥7.2%
• Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy

You may not qualify if:

• Taken prednisone or cortisone medications in the previous 30 days
• Currently pregnant or planning pregnancy during the study period
• Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
• Unable to follow the study protocol
• Unable to speak, read and write in English

Sponsors & Collaborators

• HealthPartners Institute: lead
• International Diabetes Center at Park Nicollet: collaborator
• Abbott Diabetes Care: collaborator

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

• Roger S Mazze, PhD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

• Elinor S Strock, APRN, BC

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 26, 2015

Record last verified: 2013-04

Locations

US (1)