Diabetes Mellitus, Type 2NCT01954771

SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

A study testing SMBG and CGMS in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Coronary Artery Disease
What is being tested?: SMBG and CGMS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteChina
Study dates: Jun 2013to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

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)

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.

Conditions: Diabetes Mellitus, Type 2, Coronary Artery Disease
Being tested: SMBG, CGMS
Keywords: Diabetes mellitus, Coronary artery disease, SMBG, Elderly
Medical subject headings: Diabetes Mellitus, Type 2, Coronary Artery Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMBGBehavioural
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.
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.

Study groups in NCT01954771
Study group	Role	What they receive
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. Receives: Behavioral: SMBG; Other: 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. Receives: Behavioral: SMBG; Other: 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. Receives: Behavioral: SMBG; Other: CGMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 weeks

Secondary outcomes (3)

The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
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)
Measured: 12 weeks
Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).
Measured: 12 weeks
HbA1c(%) at Endpoint
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jun 2016

First posted7 Oct 2013 (estimated)
Study startJun 2013
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01954771
Sponsor's protocol ID: Z131100004013044
Status last verified: Jun 2017
First submitted: 2 Sep 2013
Last updated: 27 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 18784090
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.
PubMed 19092168
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.
PubMed 18227477
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.
PubMed 20886203
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.
PubMed 26954412
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.
PubMed 26392171
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.
PubMed 26272739
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.
PubMed 12351471

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01954771
Acronym / sponsor ID: Z131100004013044
Conditions: Diabetes Mellitus, Type 2, Coronary Artery Disease
Keywords: Diabetes mellitus, Coronary artery disease, SMBG, Elderly
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Beijing Anzhen HospitalUniversity, hospital or other
Study start: Jun 2013
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 7 Oct 2013 (estimated)
Results: Posted 27 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control Group	Active comparator	Behavioral: SMBG, Other: CGMSPatients 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.
SMBG-4 Group	Active comparator	Behavioral: SMBG, Other: CGMSCapillary 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	Active comparator	Behavioral: SMBG, Other: CGMSCapillary 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMBGControl 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.	Behavioural	Control Group, SMBG-4 Group, SMBG-7 Group
CGMSIn 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.	Other	Control Group, SMBG-4 Group, SMBG-7 Group

Primary outcome

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).

3 secondary outcomes

The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
Time frame: 12 weeks
Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
Time frame: 12 weeks
HbA1c(%) at Endpoint
Time frame: 12 weeks

Results and safety

Results posted to the registry on 27 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	29	22
SMBG-4 Group	32	29
SMBG-7 Group	28	25

Primary outcome: Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: mmol/L

Measure	Control Group n = 29	SMBG-4 Group n = 32	SMBG-7 Group n = 28
Peak at baseline	8.86 (7.44 to 10.43)	8.72 (7.59 to 10.22)	8.80 (7.13 to 9.88)
Nadir at baseline	6.87 (5.34 to 7.65)	6.05 (5.60 to 6.93)	6.15 (4.95 to 7.45)
Peak at endpoint	8.74 (7.68 to 10.02)	8.00 (6.34 to 8.79)	8.68 (7.12 to 9.80)
Nadir at endpoint	6.32 (5.41 to 7.59)	6.55 (5.60 to 7.81)	6.44 (5.89 to 8.14)

Population analysed: 13 patients did not followed the study protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	7 of 29 (24.1%)	16 of 29 (55.2%)	Not reported
SMBG-4 Group	4 of 32 (12.5%)	20 of 32 (62.5%)	Not reported
SMBG-7 Group	7 of 28 (25%)	19 of 28 (67.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18784090Holman 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.
Background: PubMed 19092168Skyler 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.
Background: PubMed 18227477Monnier 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.
Background: PubMed 20886203Borg 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.
Background: PubMed 26954412Lipska 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.
Background: PubMed 26392171Wang 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.
Background: PubMed 26272739Munshi 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.
Background: PubMed 12351471Hoffman 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yingsheng Zhou, MD; PhD principal investigator

Capital Medical University Affiliated Beijing Anzhen Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SMBG and CGMS in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954771, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.