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

NCT01170208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-01-27

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Hygieia, Inc

    collaborator INDUSTRY

  • International Diabetes Center at Park Nicollet

    collaborator OTHER

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Richard M Bergenstal, MD · International Diabetes Center at Park Nicollet

  • Eran Bashan, PhD · Hygieia, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170208 on ClinicalTrials.gov