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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes, Insulin

Intervention / Treatment
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* Device: insulin dose software


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group I<br>Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting and insulin dose software. | Device: insulin dose software<br>* 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.<br>* Other names: blood glucose meter;|
| Other: Group II<br>Type 2 diabetes treated with basal-bolustherapy and insulin dose software. | Device: insulin dose software<br>* 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.<br>* Other names: blood glucose meter;|
| Other: Group III<br>Type 2 diabetes treated with biphasic insulin and insulin dose software. | Device: insulin dose software<br>* 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.<br>* Other names: blood glucose meter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weekly Mean Blood Glucose From Week 4 to Week 16 |  | Twelve week period from week 4 to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in HbA1c. |  | Twelve week period from week 4 to week 16 | 
| Reduction in Fructosamine. |  | 12 week period from Week 4 to Week 16 | 
| Incidence of Severe or Serious Hypoglycemia. |  | January 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin, dosage software