Improved Glycemic Control in Adult Subjects With Type 1 Diabetes on MDI Using Insulin Guidance Software

Completed

Conditions studied: Diabetes

In brief

140 subjects will be enrolled into the clinical study and randomized into the Control Group or the Experimental Group by block randomization. The subjects must meet all inclusion and none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits. The Baseline Visit will consist of a complete history, vitals, a physical examination and completion of the consent and screening process. All clinic visits, except for the Baseline Visit will include meter/PDA download. In addition, meter education will be provided to all subjects, and PDA education will be provided to the Experimental group at the Baseline Visit and 2-Week Visit as needed to ensure subject understanding. The phone visits will consist of a history including any changes in insulin dose, and any hypoglycemic events, hyperglycemic events, or other adverse events that have occurred since the last clinic visit. The primary endpoint in this study was to show a reduction in A1c of at least 0.4% or higher in the insulin guidance software group at 6 months and/or 1 year.

Key facts

Study ID

NCT00552734

Run by

University of Colorado, Denver

People needed

123

Starts

2005-07-01

Expected to finish

2007-05-01

Last updated by the study team

2015-08-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female, 18 to 60 years of age
• Diagnosed with Type 1 diabetes mellitus at least six months
• HbA1c 7.5% and 11.0% at screening
• Insulin dose 0.5 - 2.0 units/kg
• Hematocrit between 25% and 65%
• Weight 100-300 pounds
• On a dual insulin therapy supported by Accu-Chek Insulin Advisor software
• On a "day shift" schedule (typical day begins before noon)
• Willing to perform a minimum of three blood glucose tests per day - before breakfast, before lunch, and before dinner (standard of care)
• Willing to complete at least 7 clinic visits in 12 months (Baseline, 2-Week, 6-Week, 3-Month, 6-Month, 9-Month, and 12-Month)
• Willing to complete 3 study phone calls conducted by study coordinator (4.5-month, 7.5-Month and 10.5-Month)
• Able and willing to provide written informed consent to participate
• Willing to comply with the study protocol
• Willing to be randomized into either the Control Group or the Experimental Group

You may not qualify if…

• On insulin pump therapy
• On oral, inhaled or pre-mixed insulin
• Engaged in a minimum of 30 minutes of cardiovascular (aerobic) exercise 5 days out of a 7-day week
• Conditions that can cause significant increase of the insulin sensitivity factor, such as a steroid therapy, diabetic ketosis, insulin-resistant syndrome
• Creatinine above 2.5mg/dl, renal transplantation or currently undergoing kidney dialysis
• Pregnant or intends to become pregnant during the course of the study
• Undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer
• Plan to travel to a different time zone more than three times per month
• Clinical signs or symptoms of liver disease such as jaundice
• Diagnosis of acute or chronic hepatitis
• Diagnosis of hemoglobinopathy or chronic anemia
• Severe unexplained hypoglycemia in the past 3 months that required ED admission
• Participation in another clinical trial in the past 1 month
• Weight under 100 pounds or over 300 pounds

Where it is running

• University of Colorado Health Sciences Center, Barbara Davis Center for Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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