Skip to main content
OpenTrials
Completed

NCT Number: NCT01954771

SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University Affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMBG

Behavioral

Control Group Patients will receive conventional care and keep on their usual SMBG methods. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.

SMBG-4 Group 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.

SMBG-7 Group 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.

CGMS

Other

In this study, according to the protocol, all the patients will follow their prespecified SMBG methods and periodically visit doctor, but therapies will not be adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.

Primary outcomes

  1. Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)

    Time frame: 12 weeks

    The peak value:>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).

Secondary outcomes

  1. The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS

    Time frame: 12 weeks

    A correlation coefficient of 0.5 is defined as large effect size.(Cohen Jacob.Statistical power analysis for the the behavioral sciences.2nd edition.Lawrence Erlbaum Associates.1988:80)

  2. Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS

    Time frame: 12 weeks

    Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).

  3. HbA1c(%) at Endpoint

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2013
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.