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Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus (BPK003)

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ClinicalTrials.gov Identifier: NCT00943787
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Diabetes Mellitus, Type 1
Intervention Procedure: Hyperinsulinemic, euglycemic and hypoglycemic clamp
Enrollment 41
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Adults With T1DM From Subjects
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 41
Completed 34
Not Completed 7
Reason Not Completed
Physician Decision             4
Withdrawal by Subject             3
Arm/Group Title Adults With T1DM From Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
37  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
14
  41.2%
Male
20
  58.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
Glycosylated hembglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 34 participants
7.6  (0.21)
1.Primary Outcome
Title Maximum Epinephrine Response (LBGI Groups)
Hide Description

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.

Time Frame 285 min (time of clamp)
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants did not have adequate epinephrine data.
Arm/Group Title Adults With T1DM From Subjects
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: pg/ml
LBGI < 2.5 495  (60)
LBGI >= 2.5 217  (40)
2.Secondary Outcome
Title Maximum Epinephrine Response (ADRR Groups)
Hide Description

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.

Time Frame 285 min (time of clamp)
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants did not have enough epinephrine data
Arm/Group Title Adults With T1DM From Subjects
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: pg/ml
ADRR < 40 417  (45)
ADRR >= 40 167  (45)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adults With T1DM From Subjects
Hide Arm/Group Description 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.
All-Cause Mortality
Adults With T1DM From Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adults With T1DM From Subjects
Affected / at Risk (%) # Events
Total   3/34 (8.82%)    
Vascular disorders   
Orthostatic Hypotension   2/34 (5.88%)  2
Vasovagal Hypotension   1/34 (2.94%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Adults With T1DM From Subjects
Affected / at Risk (%) # Events
Total   8/34 (23.53%)    
Endocrine disorders   
Hyperglycemia   2/34 (5.88%)  2
General disorders   
Lower Back Pain   1/34 (2.94%)  1
Chest Pain   1/34 (2.94%)  1
Nervous system disorders   
Dizziness   1/34 (2.94%)  1
Headache   2/34 (5.88%)  2
Skin and subcutaneous tissue disorders   
Abdomen ecchymosis near Guardian site   1/34 (2.94%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mary Oliveri
Organization: University of Virginia
Phone: 434-982-0602
Responsible Party: Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT00943787     History of Changes
Other Study ID Numbers: 12252
First Submitted: June 24, 2009
First Posted: July 22, 2009
Results First Submitted: August 8, 2014
Results First Posted: September 8, 2014
Last Update Posted: September 8, 2014