SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

Capital Medical University

Status: Completed

Conditions: Coronary Artery Disease; Diabetes Mellitus, Type 2

Treatments: Behavioral: SMBG; Other: CGMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01954771

Z131100004013044

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Patients will receive conventional care and keep on their usual SMBG(Self-monitoring of blood glucose) methods. Additionally, each patient will also wear a CGMS(continous glucose monitoring system) device for 72h in the first week and the last week, respectively.

Treatment:

Other: CGMS

Behavioral: SMBG

SMBG-4 Group

Active Comparator group

Description:

Capillary glucose level is measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.

Treatment:

Other: CGMS

Behavioral: SMBG

SMBG-7 Group

Active Comparator group

Description:

Capillary glucose level is measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.

Treatment:

Other: CGMS

Behavioral: SMBG