N/A
Completed N=124
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01237301 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Percentage Change in Hemoglobin A1c — -1.12; -0.82 percentage of HbA1c
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Hemoglobin A1c |
-1.12; -0.82 | — |
| SECONDARY Glucose Exposure (Area Under the Diurnal Median Curve) |
-615.98; -522.88 | — |
| SECONDARY Percent of Time in Hypoglycemia Range |
-0.42; 0.14 | — |
| SECONDARY Change From Baseline in CGM Glucose Variability |
-8.36; -5.91 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01237301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.