Clinical trial NCT01954771: SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD
Official title: A Prospective, Randomized, Controlled Study on Self-monitoring of Blood Glucose (SMBG) Protocols in Predicting Glucose Levels in Senior Patients With Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease (CAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Coronary Artery Disease
Keywords: Diabetes mellitus
Coronary artery disease
SMBG
Elderly
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 89
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
timeFrame: 12 weeks
Secondary outcomes:
measure: The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
timeFrame: 12 weeks
measure: Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
timeFrame: 12 weeks
measure: HbA1c(%) at Endpoint
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University Affiliated Beijing Anzhen Hospital
name: Yingsheng Zhou, MD; PhD
role: PRINCIPAL_INVESTIGATOR
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