Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. The secondary objective is to determine the benefit of using CGM for clinical diabetes management decision-making.

Detailed Description
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This study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes: Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM device. This device has been approved for use by the U.S. Food and Drug Administration (FDA).

Official Title
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Comparison of Clinical Decisions and Outcomes Employing a Treat to Target Design for Subjects With Type 2 Diabetes Randomized to Either SMBG or CGM

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: CGM Group
* Device: SMBG Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of CGM) Clinical diagnosis of type 2 diabetes HbA1c ≥7.0% Diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with or without metformin. Exclusion Criteria: Treated with Thiazolidinediones (TZD) Administered 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 HbA1c <7.0% Unable to follow the study protocol Unable to speak, read and write in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM Group<br>Wear an unblinded CGM for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use real time continuous glucose monitoring (rt CGM). | Device: CGM Group<br>* Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.<br>* Other names: AccuChek Aviva blood glucose meter;|
| Active Comparator: SMBG Group<br>Use SMBG 4 to 7 times a day for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use structured self monitoring blood glucose (stSMBG) and periodic, blinded continuous glucose monitoring (CGM). | Device: SMBG Group<br>* Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks.<br>* Other names: DexCom SevenPlus CGM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Hemoglobin A1c |  | 2 week baseline to 16 week final | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Exposure (Area Under the Diurnal Median Curve) | The secondary objective is to determine the incremental benefit of CGM for clinical decision-making by using (area under the diurnal median curve). Data was collected to create the curve at every hour of modal day. Example: hours 1-24 of each day. Modal day reflects 14 days worth of CGM data aggregated into a single 24 hour day graph. | 16 weeks | 
| Percent of Time in Hypoglycemia Range | The secondary objective is to determine the incremental benefit of CGM for clinical decision-making using percent time in hypoglycemia range (< 50 mg/dL). Numerator: amount of time with a value of 49 mg/dL or less. Denominator: total amount of time of CGM measurement. CGM used for this study produced measurements once every 15 minutes or 360 times per day. | 16 weeks | 
| Change From Baseline in CGM Glucose Variability | Glucose Variability - Interquartile Range used to determine incremental benefit of CGM for clinical decision making. IQR results reflect the change delta from baseline to 16 weeks. IQR is calculated for each subject at each visit. The change in IQR was calculated as final IQR minus baseline IQR. This measure represents an average of the individual subjects IQR delta (baseline to 16 weeks/final). | Baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Continuous Glucose Monitoring