Carvedilol in Treating Hypoglycemia Unawareness
Hypoglycemia Unawareness
About this trial
This is an interventional treatment trial for Hypoglycemia Unawareness focused on measuring Type 1 Diabetes Mellitus, β-blocker
Eligibility Criteria
Inclusion Criteria:
- History of Type 1 diabetes mellitus for more than 5 years
- Age > 18 years
- Presence of impaired hypoglycemia awareness/unawareness
- Intensive insulin treatment as defined by multiple daily insulin injections (3 or more) or insulin pump therapy
- Negative pregnancy test
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion Criteria:
- Major medical disorders (including liver disease, cardiovascular disease, kidney disease, chronic obstructive pulmonary disease, asthma, active malignancy or HIV)
- Overt diabetes complications (neuropathy, nephropathy, retinopathy)
- Presence of anemia
- Current or recent use of beta-blocker therapy
- Use of diuretics
- Allergies or contraindications to beta-blockers or heparin
- Use of benzodiazepines
- Alcohol, drug or medication abuse
- Frequent use of acetaminophen
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Carvedilol 3.125 mg
Carvedilol 2.5 mg
Placebo capsule
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.