N/A
N=89
SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD
Diabetes Mellitus, Type 2 · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01954771 ↗Enrolled (actual)
89
Serious AEs
20.2%
Results posted
Jul 2017
Primary outcome: Primary: Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) — 8.86; 8.72; 8.80; 6.87 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SMBG (Behavioral); CGMS (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Beijing Anzhen Hospital
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) |
8.86; 8.72; 8.80; 6.87; 6.05; 6.15 | — |
| SECONDARY The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS |
7.92; 8.00; 7.81; 7.62; 7.24; 7.76 | <0.001 sig |
| SECONDARY Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS |
4; 3; 7; 3; 1; 3 | — |
| SECONDARY HbA1c(%) at Endpoint |
6.9; 6.7; 6.6 | — |
Summary
Self-monitoring of blood glucose (SMBG) is a common way to assess glycemic control in diabetes management. Multiple times of blood glucose measurements by fingerstick in the same day are of tough challenge to it. The changes and variations of glucose excursion in senior diabetics with Coronary Artery Disease (CAD)involve a safety issue besides glycated hemoglobin (GHb) value. The goal of this study is to explore modified SMBG protocols for precisely monitoring and predicting glycemic excursion, variability in senior type 2 diabetics with CAD.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 2 diabetes
- Clinical diagnosis of coronary artery disease
- Age ≥65 years
- The blood glucose is controlled by diets and (or) oral hypoglycemic drugs
- BMI≤28 kg/m²
- Being able to monitor and record capillary glucose value by themselves at home
Exclusion Criteria
- Diabetic ketoacidosis (DKA)
- Acute cardiovascular events
- Anemia
- Insulin treatment
- Incapable to perform SMBG at home
Data sourced from ClinicalTrials.gov (NCT01954771). 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.