Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Hygieia, Inc
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01170208
First received: July 22, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 will last for 16-weeks and includes 3-4 clinic visits and a series of weekly telephone calls from the study team (minimum of 12 calls). Participants will be provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or drop off a copy of the Study Log Sheet. This information will be entered by the IDC study team into the computer software program. The IDC study team will review the information from the software and, based on the IDC's study team approval, any insulin dose changes will be communicated back to the patient by phone or fax.


Condition Intervention
Diabetes
Insulin
Device: insulin dose software

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Weekly Mean Blood Glucose [ Time Frame: Twelve week period from week 4 to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Evaluation of ―Over-ride‖ to Determine if the Reason for ―Over-ride‖ Will Affect a Change in the Algorithm. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
  • Reduction in HbA1c. [ Time Frame: January 2011 ] [ Designated as safety issue: No ]
  • Reduction in Fructosamine. [ Time Frame: January 2011 ] [ Designated as safety issue: No ]
  • Incidence of Severe or Serious Hypoglycemia. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group I
Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
Device: insulin dose software
The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.
Other Name: blood glucose meter
Group II
Type 2 diabetes treated with basal-bolustherapy
Device: insulin dose software
The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.
Other Name: blood glucose meter
Group III
Type 2 diabetes treated with biphasic insulin
Device: insulin dose software
The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.
Other Name: blood glucose meter

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 blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin dosage in a patient with diabetes.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170208

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Hygieia, Inc
International Diabetes Center at Park Nicollet
Investigators
Principal Investigator: Richard M Bergenstal, MD International Diabetes Center at Park Nicollet
Study Director: Eran Bashan, PhD Hygieia, Inc
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01170208     History of Changes
Other Study ID Numbers: 03985-10-A, R41DK085974
Study First Received: July 22, 2010
Results First Received: September 5, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
insulin
dosage software

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014