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DiabetesNCT01170208

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

A study testing insulin dose software in people with Diabetes and Insulin, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Diabetes, Insulin
What is being tested?
insulin dose software
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
Jun 2010to Mar 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Diabetes, Insulin
Being tested
insulin dose software
Keywords
insulin, dosage software
Medical subject headings
Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin dose softwareDevice

    Also called blood glucose meter

    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.

Study groups in NCT01170208
Study groupRoleWhat they receive
Group IOtherType 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting and insulin dose software.
Receives: Device: insulin dose software
Group IIOtherType 2 diabetes treated with basal-bolustherapy and insulin dose software.
Receives: Device: insulin dose software
Group IIIOtherType 2 diabetes treated with biphasic insulin and insulin dose software.
Receives: Device: insulin dose software

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Twelve week period from week 4 to week 16

Secondary outcomes (3)

  1. Reduction in HbA1c.

    Measured: Twelve week period from week 4 to week 16

  2. Reduction in Fructosamine.

    Measured: 12 week period from Week 4 to Week 16

  3. Incidence of Severe or Serious Hypoglycemia.

    Measured: January 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01170208
Sponsor's protocol ID
03985-10-A
Other IDs
R41DK085974
Status last verified
Jan 2014
First submitted
22 Jul 2010
Last updated
27 Jan 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 8366922

  • 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.

    PubMed 15983302

  • 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.

    PubMed 18364392

  • 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.

    PubMed 22568777

Questions about this trial

What is this clinical trial studying?

A study testing insulin dose software in people with Diabetes and Insulin, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weekly Mean Blood Glucose From Week 4 to Week 16 (time frame: Twelve week period from week 4 to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01170208, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.

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