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

Purpose

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.

Condition	Intervention
Diabetes	Device: Insulin Guidance Software

MedlinePlus related topics:

Diabetes Diabetes Type 1

ChemIDplus related topics:

Insulin Dextrose BaseLine Proparacaine Proparacaine hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Prospective

Official Title:	Glycemic Control and Prevention of Hypoglycemia in Intensively Treated Subjects With Type 1 Diabetes Using Accu-Chek® Advisor Insulin Guidance Software

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Primary Outcome Measures:

Decrease in A1c of at least 0.4% in the insulin guidance software group as compared to the control group at 6 months and/or 1 year. [ Time Frame: 1 year ]

Secondary Outcome Measures:

Hypoglycemic episodes, weight gain, insulin dose, frequency of self monitoring of glucose [ Time Frame: 1 year ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	123
Study Start Date:	July 2005
Study Completion Date:	May 2007

Groups/Cohorts	Assigned Interventions
Control The other half of the patients were randomized to the control group who were followed for their routine diabetes care and had to visit the clinic on the same schedule as the experimental group.	Device: Insulin Guidance Software At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.
Experimental Half of the subjects were randomized to this group using insulin guidance software on a PDA to adjust their insulin dose at home based on the prescription provided by the provider.	Device: Insulin Guidance Software At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

123 adult subjects ages 18-60 with type 1 diabetes on mulitiple daily injections

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552734

Locations


United States, Colorado
	University of Colorado Health Sciences Center, Barbara Davis Center for Diabetes
	Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Investigators


Principal Investigator:	Satish K Garg, MD	University of Colorado at Denver and Health Sciences Center

More Information

Study ID Numbers:	COMIRB Protocol # 04-0834
First Received:	October 31, 2007
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00552734
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado at Denver and Health Sciences Center:

Type 1 diabetes

Improved glycemic control

Glucose excursions

Target range glucose levels

Insulin guidance software

Advisor

Study placed in the following topic categories:

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus, Type 1

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Proxymetacaine

Metabolic disorder

Glucose Metabolism Disorders

Hypoglycemia

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Immune System Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	University of Colorado at Denver and Health Sciences Center
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00552734