Status:
COMPLETED
Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Insulin
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The purpose of the study is to determine the effectiveness and safety of the computer software program in providing insulin dosage recommendations. Participation in the study for 60 research subjects ...
Detailed Description
Hygieia, Inc. is developing a device intended for use by insulin-requiring patients with diabetes. It will be a pocket-sized, hand-held device, combining a glucose meter with software that analyzes bl...
Eligibility Criteria
Inclusion
- GROUP I
- Have been clinically diagnosed with type-1 diabetes for at least 1-year
- Have an HgbA1c of 7.4% or higher
- Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine), per day. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months
- Is currently using an insulin/carbohydrate ratio to decide how much short-acting insulin to take before meals and must be able to use the gram versus choice method of carbohydrate counting.
- GROUP II
- Have been clinically diagnosed with type-2 diabetes for at least 1-year
- Have an HgbA1c of 7.4% or higher
- Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine) per day and. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months
- May be using other diabetes agent(s) at a stable dose for the last 3-months.
- GROUP III
- Have been clinically diagnosed with type-2 diabetes for at least 1-year
- Have an HgbA1c of 7.8% or higher
- Take twice daily biphasic Insulin (e.g. HumaLog® Mix 75/25, NovoLog® Mix 70/30) or premixed insulin (i.e. Humulin® 70/30, Novolin® 70/30, NPH/Regular insulin 70/30) with a total daily insulin dose of 25 units and have been using the same insulin regimen for the past 3-months
- May be using other diabetes agent(s) at a stable dose for the last 3-months.
Exclusion
- Have a history of greater than 2 episodes of severe hypoglycemia in the past year, or have hypoglycemic unawareness when glucose levels are less than or equal to 50 mg/dl
- Have a significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol
- Have any severe cardiovascular disease including a history of congestive heart failure (New York Heart Association \[NYHA\] 3 or 4), unstable angina, myocardial infarction or stroke that occurred within the 6-months preceding enrollment
- Have known active anemia with a hemotocrit less than 25% in women or 30% in men
- Have known history of renal disease (e.g., serum creatinine level \>2.0 mg/dl or eGFR \< 30 ml/min)
- Have active cancer or cancer in the past 2-years (except non-melanoma skin cancer
- Have history of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values)
- Have a body mass index (BMI) \> 45 kg/m2; and/or
- Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01170208
Start Date
June 1 2010
End Date
March 1 2011
Last Update
January 27 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Diabetes Center
Minneapolis, Minnesota, United States, 55416