NCT01954771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2017

Completed
Last Updated

July 27, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

September 2, 2013

Results QC Date

August 31, 2016

Last Update Submit

June 27, 2017

Conditions

Diabetes Mellitus, Type 2Coronary Artery Disease

Keywords

Diabetes mellitusCoronary artery diseaseSMBGElderly

Outcome Measures

Primary Outcomes (1)

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

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

    12 weeks

Secondary Outcomes (3)

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

    12 weeks

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

    12 weeks

  • HbA1c(%) at Endpoint

    12 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: SMBGOther: CGMS

SMBG-4 Group

ACTIVE COMPARATOR

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.

Behavioral: SMBGOther: CGMS

SMBG-7 Group

ACTIVE COMPARATOR

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.

Behavioral: SMBGOther: CGMS

Interventions

SMBGBEHAVIORAL

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.

Control GroupSMBG-4 GroupSMBG-7 Group
CGMSOTHER

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.

Control GroupSMBG-4 GroupSMBG-7 Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetic ketoacidosis (DKA)
  • Acute cardiovascular events
  • Anemia
  • Insulin treatment
  • Incapable to perform SMBG at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University Affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (8)

  • Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

    PMID: 18784090BACKGROUND

  • Skyler JS, Bergenstal R, Bonow RO, Buse J, Deedwania P, Gale EA, Howard BV, Kirkman MS, Kosiborod M, Reaven P, Sherwin RS; American Diabetes Association; American College of Cardiology Foundation; American Heart Association. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009 Jan;32(1):187-92. doi: 10.2337/dc08-9026. Epub 2008 Dec 17. No abstract available.

    PMID: 19092168BACKGROUND

  • Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241.

    PMID: 18227477BACKGROUND

  • Borg R, Kuenen JC, Carstensen B, Zheng H, Nathan DM, Heine RJ, Nerup J, Borch-Johnsen K, Witte DR; ADAG Study Group. HbA(1)(c) and mean blood glucose show stronger associations with cardiovascular disease risk factors than do postprandial glycaemia or glucose variability in persons with diabetes: the A1C-Derived Average Glucose (ADAG) study. Diabetologia. 2011 Jan;54(1):69-72. doi: 10.1007/s00125-010-1918-2. Epub 2010 Oct 1.

    PMID: 20886203BACKGROUND

  • Lipska KJ, Krumholz H, Soones T, Lee SJ. Polypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes. JAMA. 2016 Mar 8;315(10):1034-45. doi: 10.1001/jama.2016.0299.

    PMID: 26954412BACKGROUND

  • Wang P, Huang R, Lu S, Xia W, Sun H, Sun J, Cai R, Wang S. HbA1c below 7% as the goal of glucose control fails to maximize the cardiovascular benefits: a meta-analysis. Cardiovasc Diabetol. 2015 Sep 22;14:124. doi: 10.1186/s12933-015-0285-1.

    PMID: 26392171BACKGROUND

  • Munshi MN, Segal AR, Slyne C, Samur AA, Brooks KM, Horton ES. Shortfalls of the use of HbA1C-derived eAG in older adults with diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):60-65. doi: 10.1016/j.diabres.2015.07.012. Epub 2015 Aug 3.

    PMID: 26272739BACKGROUND

  • Hoffman RM, Shah JH, Wendel CS, Duckworth WC, Adam KD, Bokhari SU, Dalton C, Murata GH; Diabetes Outcome in Veterans Study. Evaluating once- and twice-daily self-monitored blood glucose testing strategies for stable insulin-treated patients with type 2 diabetes : the diabetes outcomes in veterans study. Diabetes Care. 2002 Oct;25(10):1744-8. doi: 10.2337/diacare.25.10.1744.

    PMID: 12351471BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Limitations and Caveats

This clinical trial population may not be representative of all patients. Because patients missed clinic visits in three months by reason of vacation tour, or complained about frequent blood samplings, 14.6% of all did not follow the study protocol.

Results Point of Contact

Title
Dr.Yingsheng Zhou
Organization
Beijing Anzhen Hospital
zys626@aliyun.com
0086-010-64456185

Study Officials

  • Yingsheng Zhou, MD; PhD

    Capital Medical University Affiliated Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endocrinology and Metabolism Department of Capital Medical University Affiliated Beijing Anzhen Hospital

Study Record Dates

First Submitted

September 2, 2013

First Posted

October 7, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 27, 2017

Results First Posted

July 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)