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Insulin Dose Titration System Using a Short Messaging Service (SMS) Automatically Produced by a Knowledge Matrix

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insulin dose titration system using a SMS
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Insulin dose titration system

Eligibility Criteria

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

Inclusion Criteria:

  • patients with type 2 diabetes suboptimally controlled on their previous antidiabetic treatment were included
  • age ≥ 18 years
  • on antidiabetic treatment (any oral and/or insulin therapy) for > 6 months
  • A1C levels > 7.0 and < 12.0%
  • BMI values < 35 kg/m2

Exclusion Criteria:

  • type 1 diabetes
  • renal dysfunction (defined as creatinine blood level > 2.0 mg/dL)
  • hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level > 2.5 times the upper normal limit)
  • hypoglycemic unawareness
  • pregnancy
  • severe retinopathy
  • illiteracy
  • elderly over than 70 yrs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    insulin titration by specialized system

    Arm Description

    Insulin dose titration system by using a SMS automatically produced by a knowledge matrix

    Outcomes

    Primary Outcome Measures

    The primary objective was to compare the mean changes of A1C from baseline to end point between two groups.

    Secondary Outcome Measures

    Secondary objectives included the proportion of patients to achieve A1C level below 7.0%; incidence of hypoglycemic episodes; change in body weight; and insulin dose.

    Full Information

    First Posted
    July 27, 2009
    Last Updated
    July 28, 2009
    Sponsor
    Hallym University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00948584
    Brief Title
    Insulin Dose Titration System Using a Short Messaging Service (SMS) Automatically Produced by a Knowledge Matrix
    Official Title
    Insulin Dose Titration System in Diabetic Patients Using a Short Messaging Service Automatically Produced by a Knowledge Matrix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hallym University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators designed the system in type 2 diabetic patients treated with long acting insulin to produce an automatic adjustment of insulin dose based on real time glucose level data and to provide to the patients the needed insulin dose by using a short message service (SMS) and apply to the clinical practice.
    Detailed Description
    Most patients with type 2 diabetes will, in time, need insulin therapy. Starting insulin poses considerable challenges. Also, improving glycemic control with insulin therapy often requires periodic dose adjustments based on glycemic response. Therefore, how to adjust their insulin doses are very important for improvement of glycemic control. Long acting insulin offers the benefit of a more consistent pharmacological dynamic with less hypoglycemia. Therefore, long acting insulin dose adjustments are widely used by patients based on simplified insulin dosing algorithms. In the management of diabetes, it is important to maintain an intimate and continuous doctor-patient relationship. To achieve an optimal glucose level and to prevent diabetic complications, frequent contact with a medical doctor is recommended, but this causes an increased amount of medical expense. In recent years, web and phone delivery of self-management programs have emerged as popular approaches to the management of diabetes. The major focus of the system was support for blood glucose monitoring with substantive feedback from expert to help interpret results of glucose-level values. Moreover, with this system the patients could be advised to determine the amount of insulin required. However, despite of using these programs, it can take a significant amount of effort and time for physicians to look over each patient's data, formulate an appropriate message, and send it to the patients. Accordingly, computerized, knowledge-based medical treatment advice systems will provide more abundant medical advices, also can be more economic than the previous systems, in which medical personnel were required for the same process. Recently we designed an Internet-based diabetic patient management using short message service (SMS) that was automatically produced by a knowledge matrix. Moreover, we reported this unique system has shown the great efficacy in glucose control. In this study, we designed the system in patients treated with long acting insulin to produce an automatic adjustment of insulin dose based on real time glucose level data and to provide to the patients the needed insulin dose by using a SMS and apply to the clinical practice with diabetic patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Diabetes Mellitus, Type 2, Insulin dose titration system

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    insulin titration by specialized system
    Arm Type
    Experimental
    Arm Description
    Insulin dose titration system by using a SMS automatically produced by a knowledge matrix
    Intervention Type
    Other
    Intervention Name(s)
    Insulin dose titration system using a SMS
    Other Intervention Name(s)
    insulin used in this study = Lantus (insulin glargine)
    Intervention Description
    We applied 'Insulin dose titration system in diabetic patients using a short messaging service automatically produced by a knowledge matrix' for 12 weeks in the intervention group. In the control group, a conventional insulin titration schedule was used. The insulin used in this study was Lantus (insulin glargine).
    Primary Outcome Measure Information:
    Title
    The primary objective was to compare the mean changes of A1C from baseline to end point between two groups.
    Time Frame
    three months
    Secondary Outcome Measure Information:
    Title
    Secondary objectives included the proportion of patients to achieve A1C level below 7.0%; incidence of hypoglycemic episodes; change in body weight; and insulin dose.
    Time Frame
    three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with type 2 diabetes suboptimally controlled on their previous antidiabetic treatment were included age ≥ 18 years on antidiabetic treatment (any oral and/or insulin therapy) for > 6 months A1C levels > 7.0 and < 12.0% BMI values < 35 kg/m2 Exclusion Criteria: type 1 diabetes renal dysfunction (defined as creatinine blood level > 2.0 mg/dL) hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level > 2.5 times the upper normal limit) hypoglycemic unawareness pregnancy severe retinopathy illiteracy elderly over than 70 yrs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chul Sik Kim, MD, PhD
    Organizational Affiliation
    Hallym University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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