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SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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