NCT01170208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 6, 2014

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

July 22, 2010

Results QC Date

September 5, 2013

Last Update Submit

January 16, 2020

Conditions

DiabetesInsulin

Keywords

insulindosage software

Outcome Measures

Primary Outcomes (1)

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

    Twelve week period from week 4 to week 16

Secondary Outcomes (3)

  • 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

Study Arms (3)

Group I

OTHER

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

Device: insulin dose software

Group II

OTHER

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

Device: insulin dose software

Group III

OTHER

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

Device: insulin dose software

Interventions

insulin dose softwareDEVICE

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.

Also known as: blood glucose meter
Group IGroup IIGroup III

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (4)

  • 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.

    PMID: 8366922BACKGROUND

  • 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.

    PMID: 15983302BACKGROUND

  • 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.

    PMID: 18364392BACKGROUND

  • 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.

    PMID: 22568777DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Limitations and Caveats

Study was limited by lack of a control group.

Results Point of Contact

Title
Dr. Richard Bergenstal
Organization
International Diabetes Center
richard.bergenstal@parknicollet.com
952-993-3796

Study Officials

  • Richard M Bergenstal, MD

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

  • Eran Bashan, PhD

    Hygieia, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 27, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 27, 2020

Results First Posted

January 6, 2014

Record last verified: 2014-01

Locations

US(1)