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

Primary Purpose

Diabetes, Insulin

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

insulin dose software

About this trial

This is an interventional treatment trial for Diabetes focused on measuring insulin, dosage software

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

International Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Group I

Group II

Group III

Arm Description

Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting and insulin dose software.

Type 2 diabetes treated with basal-bolustherapy and insulin dose software.

Type 2 diabetes treated with biphasic insulin and insulin dose software.

Outcomes

Primary Outcome Measures

Change in Weekly Mean Blood Glucose From Week 4 to Week 16

Secondary Outcome Measures

Reduction in HbA1c.

Reduction in Fructosamine.

Incidence of Severe or Serious Hypoglycemia.

Full Information

NCT ID

NCT01170208

First Posted

July 22, 2010

Last Updated

January 16, 2020

Sponsor

HealthPartners Institute

Collaborators

National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Hygieia, Inc, International Diabetes Center at Park Nicollet

1. Study Identification

Unique Protocol Identification Number

NCT01170208

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

Collaborators

National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Hygieia, Inc, International Diabetes Center at Park Nicollet

4. Oversight

Data Monitoring Committee

5. Study Description

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 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Insulin

Keywords

insulin, dosage software

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Other

Arm Description

Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting and insulin dose software.

Arm Title

Group II

Arm Type

Other

Arm Description

Type 2 diabetes treated with basal-bolustherapy and insulin dose software.

Arm Title

Group III

Arm Type

Other

Arm Description

Type 2 diabetes treated with biphasic insulin and insulin dose software.

Intervention Type

Device

Intervention Name(s)

insulin dose software

Other Intervention Name(s)

blood glucose meter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Weekly Mean Blood Glucose From Week 4 to Week 16

Time Frame

Twelve week period from week 4 to week 16

Secondary Outcome Measure Information:

Title

Reduction in HbA1c.

Time Frame

Twelve week period from week 4 to week 16

Title

Reduction in Fructosamine.

Time Frame

12 week period from Week 4 to Week 16

Title

Incidence of Severe or Serious Hypoglycemia.

Time Frame

January 2011

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard M Bergenstal, MD

Organizational Affiliation

International Diabetes Center at Park Nicollet

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eran Bashan, PhD

Organizational Affiliation

Hygieia, Inc

Official's Role

Study Director

Facility Information:

Facility Name

International Diabetes Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8366922

Citation

Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

Results Reference

background

PubMed Identifier

15983302

Citation

Herman WH, Ilag LL, Johnson SL, Martin CL, Sinding J, Al Harthi A, Plunkett CD, LaPorte FB, Burke R, Brown MB, Halter JB, Raskin P. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care. 2005 Jul;28(7):1568-73. doi: 10.2337/diacare.28.7.1568.

Results Reference

background

PubMed Identifier

18364392

Citation

Bergenstal RM, Johnson M, Powers MA, Wynne A, Vlajnic A, Hollander P, Rendell M. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008 Jul;31(7):1305-10. doi: 10.2337/dc07-2137. Epub 2008 Mar 25.

Results Reference

background

PubMed Identifier

22568777

Citation

Bergenstal RM, Bashan E, McShane M, Johnson M, Hodish I. Can a tool that automates insulin titration be a key to diabetes management? Diabetes Technol Ther. 2012 Aug;14(8):675-82. doi: 10.1089/dia.2011.0303. Epub 2012 May 8.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/22568777

Description

Publication

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

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