Trial Outcomes & Findings for SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD (NCT NCT01954771)
NCT ID: NCT01954771
Last Updated: 2017-07-27
Results Overview
The peak value:\>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-07-27
Participant Flow
Participant milestones
| Measure |
Control Group
Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
28
|
|
Overall Study
COMPLETED
|
22
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
3
|
Reasons for withdrawal
| Measure |
Control Group
Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
Overall Study
Missing HbA1c of end-point
|
1
|
1
|
0
|
|
Overall Study
Missing CGMS of end-point
|
1
|
1
|
0
|
|
Overall Study
Missing HbA1c and CGMS of end-point
|
5
|
1
|
3
|
Baseline Characteristics
SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD
Baseline characteristics by cohort
| Measure |
Control Group
n=29 Participants
Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=32 Participants
Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=28 Participants
Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.0 years
n=5 Participants
|
70.5 years
n=7 Participants
|
67.0 years
n=5 Participants
|
69.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Insulin secretagogues
yes
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Insulin secretagogues
no
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
12 participants
n=5 Participants
|
48 participants
n=4 Participants
|
|
Other Oral Anti-diabetic Drugs
yes
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
25 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Other Oral Anti-diabetic Drugs
no
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Statins
yes
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
78 participants
n=4 Participants
|
|
Statins
no
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
β-blocker
yes
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
β-blocker
no
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
11 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Systolic blood pressure
|
125.0 mmHg
n=5 Participants
|
129.0 mmHg
n=7 Participants
|
127.0 mmHg
n=5 Participants
|
128.0 mmHg
n=4 Participants
|
|
Diastolic blood pressure
|
68.0 mmHg
n=5 Participants
|
65.5 mmHg
n=7 Participants
|
68.0 mmHg
n=5 Participants
|
67.0 mmHg
n=4 Participants
|
|
Heart rate
|
66.0 beats per minute
n=5 Participants
|
72.0 beats per minute
n=7 Participants
|
66.0 beats per minute
n=5 Participants
|
67.0 beats per minute
n=4 Participants
|
|
Body mass index
|
26.1 kg/m²
n=5 Participants
|
26.1 kg/m²
n=7 Participants
|
26.3 kg/m²
n=5 Participants
|
26.1 kg/m²
n=4 Participants
|
|
Glycated hemoglobin(Normal values range from 4-6 percent)
|
7.0 percent
n=5 Participants
|
6.8 percent
n=7 Participants
|
6.8 percent
n=5 Participants
|
6.8 percent
n=4 Participants
|
|
Hemoglobin(Normal values range from 130-175 g/L)
|
139.0 g/L
n=5 Participants
|
139.5 g/L
n=7 Participants
|
143.0 g/L
n=5 Participants
|
141.0 g/L
n=4 Participants
|
|
Fasting glucose(Normal values range from 3.9-6.1 mmol/L)
|
7.6 mmol/L
n=5 Participants
|
6.5 mmol/L
n=7 Participants
|
7.5 mmol/L
n=5 Participants
|
7.4 mmol/L
n=4 Participants
|
|
C-peptid(Normal values range from 0.78-5.19 ng/ml)
|
1.94 ng/ml
n=5 Participants
|
2.00 ng/ml
n=7 Participants
|
1.87 ng/ml
n=5 Participants
|
1.97 ng/ml
n=4 Participants
|
|
Insulin(Normal values range from 2.08-10.9 μU/ml)
|
8.8 μU/ml
n=5 Participants
|
9.2 μU/ml
n=7 Participants
|
8.1 μU/ml
n=5 Participants
|
9.0 μU/ml
n=4 Participants
|
|
Triglyceride(Normal values range from 0-1.7 mmol/L)
|
1.35 mmol/L
n=5 Participants
|
1.15 mmol/L
n=7 Participants
|
1.12 mmol/L
n=5 Participants
|
1.24 mmol/L
n=4 Participants
|
|
Total cholesterol(Normal values range from 3.1-5.2 mmol/L)
|
3.88 mmol/L
n=5 Participants
|
4.01 mmol/L
n=7 Participants
|
3.46 mmol/L
n=5 Participants
|
3.85 mmol/L
n=4 Participants
|
|
High density lipoprotein cholesterol(Normal values range from 1.04-1.55 mmol/L)
|
1.09 mmol/L
n=5 Participants
|
1.13 mmol/L
n=7 Participants
|
1.12 mmol/L
n=5 Participants
|
1.11 mmol/L
n=4 Participants
|
|
LDL-C (1.27-3.12 for normal; <2.59 at high risk factors; <1.80 at very high risk factors)
|
2.22 mmol/L
n=5 Participants
|
2.17 mmol/L
n=7 Participants
|
1.85 mmol/L
n=5 Participants
|
2.02 mmol/L
n=4 Participants
|
|
Blood urea nitrogen（Normal values range from 2.8-7.2 mmol/L）
|
5.6 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
6.2 mmol/L
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
5.9 mmol/L
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Creatinine（Normal values range from 59-104 mmol/L for male,45-84 mmol/L for female）
|
82.71 mmol/L
STANDARD_DEVIATION 15.20 • n=5 Participants
|
81.65 mmol/L
STANDARD_DEVIATION 16.49 • n=7 Participants
|
76.33 mmol/L
STANDARD_DEVIATION 18.87 • n=5 Participants
|
80.32 mmol/L
STANDARD_DEVIATION 16.91 • n=4 Participants
|
|
Urinary albumin ratio(Normal values range from 0-30 mg/g)
|
7.59 mg/g
n=5 Participants
|
9.09 mg/g
n=7 Participants
|
8.62 mg/g
n=5 Participants
|
8.62 mg/g
n=4 Participants
|
|
CKD-EPI -eGFR
|
72.72 ml/min/1.73m²
n=5 Participants
|
80.32 ml/min/1.73m²
n=7 Participants
|
87.15 ml/min/1.73m²
n=5 Participants
|
80.81 ml/min/1.73m²
n=4 Participants
|
|
MDRD-eGFR
|
79.39 ml/min/1.73m²
n=5 Participants
|
89.66 ml/min/1.73m²
n=7 Participants
|
93.86 ml/min/1.73m²
n=5 Participants
|
89.72 ml/min/1.73m²
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 13 patients did not followed the study protocol.
The peak value:\>16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).
Outcome measures
| Measure |
Control Group
n=29 Participants
SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=32 Participants
SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=28 Participants
SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Peak at baseline
|
8.86 mmol/L
Interval 7.44 to 10.43
|
8.72 mmol/L
Interval 7.59 to 10.22
|
8.80 mmol/L
Interval 7.13 to 9.88
|
|
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Nadir at baseline
|
6.87 mmol/L
Interval 5.34 to 7.65
|
6.05 mmol/L
Interval 5.6 to 6.93
|
6.15 mmol/L
Interval 4.95 to 7.45
|
|
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Peak at endpoint
|
8.74 mmol/L
Interval 7.68 to 10.02
|
8.00 mmol/L
Interval 6.34 to 8.79
|
8.68 mmol/L
Interval 7.12 to 9.8
|
|
Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)
Nadir at endpoint
|
6.32 mmol/L
Interval 5.41 to 7.59
|
6.55 mmol/L
Interval 5.6 to 7.81
|
6.44 mmol/L
Interval 5.89 to 8.14
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 13 patients did not followed the study protocol.
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)
Outcome measures
| Measure |
Control Group
n=29 Participants
SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=32 Participants
SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=28 Participants
SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
MBG from SMBG
|
7.92 mmol/L
Interval 6.99 to 8.65
|
8.00 mmol/L
Interval 7.43 to 8.83
|
7.81 mmol/L
Interval 7.28 to 8.61
|
|
The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS
MBG from CGMS at endpoint
|
7.62 mmol/L
Interval 6.94 to 8.56
|
7.24 mmol/L
Interval 6.64 to 8.74
|
7.76 mmol/L
Interval 7.05 to 8.11
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 13 patients did not followed the study protocol.
Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).
Outcome measures
| Measure |
Control Group
n=29 Participants
SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=32 Participants
SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=28 Participants
SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
SMBG
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
Baseline CGMS
|
4 participants
|
3 participants
|
7 participants
|
|
Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS
End-point CGMS
|
3 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 13 patients did not followed the study protocol.
Outcome measures
| Measure |
Control Group
n=22 Participants
SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=29 Participants
SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=25 Participants
SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
HbA1c(%) at Endpoint
|
6.9 percentage
Interval 6.2 to 7.2
|
6.7 percentage
Interval 6.1 to 7.0
|
6.6 percentage
Interval 6.4 to 7.3
|
Adverse Events
Control Group
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
SMBG-4 Group
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
SMBG-7 Group
Serious events: 7 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=29 participants at risk
Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=32 participants at risk
Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=28 participants at risk
Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
Endocrine disorders
Severe hypoglycemia (≤2.8mmol/L)
|
24.1%
7/29 • Number of events 7 • 12 weeks
Events reported according to description in study protocol.
|
12.5%
4/32 • Number of events 4 • 12 weeks
Events reported according to description in study protocol.
|
25.0%
7/28 • Number of events 7 • 12 weeks
Events reported according to description in study protocol.
|
Other adverse events
| Measure |
Control Group
n=29 participants at risk
Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-4 Group
n=32 participants at risk
Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
SMBG-7 Group
n=28 participants at risk
Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hemorrhage
|
0.00%
0/29 • 12 weeks
Events reported according to description in study protocol.
|
0.00%
0/32 • 12 weeks
Events reported according to description in study protocol.
|
0.00%
0/28 • 12 weeks
Events reported according to description in study protocol.
|
|
Endocrine disorders
Hypoglycemia (≤3.9mmol/L)
|
55.2%
16/29 • Number of events 16 • 12 weeks
Events reported according to description in study protocol.
|
62.5%
20/32 • Number of events 20 • 12 weeks
Events reported according to description in study protocol.
|
67.9%
19/28 • Number of events 19 • 12 weeks
Events reported according to description in study protocol.
|
|
Skin and subcutaneous tissue disorders
Pain
|
0.00%
0/29 • 12 weeks
Events reported according to description in study protocol.
|
0.00%
0/32 • 12 weeks
Events reported according to description in study protocol.
|
0.00%
0/28 • 12 weeks
Events reported according to description in study protocol.
|
|
Skin and subcutaneous tissue disorders
Infection
|
0.00%
0/29 • 12 weeks
Events reported according to description in study protocol.
|
0.00%
0/32 • 12 weeks
Events reported according to description in study protocol.
|
0.00%
0/28 • 12 weeks
Events reported according to description in study protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60