Trial Outcomes & Findings for Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus (NCT NCT00943787)
NCT ID: NCT00943787
Last Updated: 2014-09-08
Results Overview
Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL. Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40-55% of the variance of future significant hypoglycemia in the subsequent 3-6 months. The LBGI has established risk categories: Low Risk, LBGI \< 2.5; Moderate Risk, 2.5 \< LBGI \< 5; and High Risk, LBGI \> 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category.
COMPLETED
NA
41 participants
285 min (time of clamp)
2014-09-08
Participant Flow
Recruitment period: 2/2006-5/2009. Recruitment included outpatients at UVA clinics, former research subjects, and local advertising. All subjects ≥18 years of age and had type 1 diabetes defined by American Diabetes Association criteria or judgment of the study endocrinologist after review of the clinical history.
Participant milestones
| Measure |
Adults With T1DM From Subjects
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
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|---|---|
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Overall Study
STARTED
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41
|
|
Overall Study
COMPLETED
|
34
|
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Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Adults With T1DM From Subjects
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
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|---|---|
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Overall Study
Physician Decision
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4
|
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Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Adults With T1DM From Subjects
n=34 Participants
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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34 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
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Region of Enrollment
United States
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34 participants
n=5 Participants
|
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Glycosylated hembglobin (HbA1c)
|
7.6 percent
STANDARD_DEVIATION 0.21 • n=5 Participants
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PRIMARY outcome
Timeframe: 285 min (time of clamp)Population: 3 participants did not have adequate epinephrine data.
Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL. Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40-55% of the variance of future significant hypoglycemia in the subsequent 3-6 months. The LBGI has established risk categories: Low Risk, LBGI \< 2.5; Moderate Risk, 2.5 \< LBGI \< 5; and High Risk, LBGI \> 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category.
Outcome measures
| Measure |
Adults With T1DM From Subjects
n=31 Participants
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
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|---|---|
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Maximum Epinephrine Response (LBGI Groups)
LBGI < 2.5
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495 pg/ml
Standard Deviation 60
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Maximum Epinephrine Response (LBGI Groups)
LBGI >= 2.5
|
217 pg/ml
Standard Deviation 40
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SECONDARY outcome
Timeframe: 285 min (time of clamp)Population: 3 participants did not have enough epinephrine data
Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL. Average Daily Risk Range (ADRR) is associated with glycemic variability and risk of both hyper- and hypoglycemia. Low Risk, ADRR \< 20; Moderate Risk, 20 \< ADRR \< 40; and High Risk,ADRR \> 40.
Outcome measures
| Measure |
Adults With T1DM From Subjects
n=31 Participants
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
|
|---|---|
|
Maximum Epinephrine Response (ADRR Groups)
ADRR < 40
|
417 pg/ml
Standard Deviation 45
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Maximum Epinephrine Response (ADRR Groups)
ADRR >= 40
|
167 pg/ml
Standard Deviation 45
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Adverse Events
Adults With T1DM From Subjects
Serious adverse events
| Measure |
Adults With T1DM From Subjects
n=34 participants at risk
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
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|---|---|
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Vascular disorders
Orthostatic Hypotension
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5.9%
2/34 • Number of events 2 • 3 years
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Vascular disorders
Vasovagal Hypotension
|
2.9%
1/34 • Number of events 2 • 3 years
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Other adverse events
| Measure |
Adults With T1DM From Subjects
n=34 participants at risk
Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
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|---|---|
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Endocrine disorders
Hyperglycemia
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5.9%
2/34 • Number of events 2 • 3 years
|
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Nervous system disorders
Dizziness
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2.9%
1/34 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
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5.9%
2/34 • Number of events 2 • 3 years
|
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General disorders
Lower Back Pain
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2.9%
1/34 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Abdomen ecchymosis near Guardian site
|
2.9%
1/34 • Number of events 1 • 3 years
|
|
General disorders
Chest Pain
|
2.9%
1/34 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place