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

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ClinicalTrials.gov Identifier: NCT00948584
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : July 29, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: Insulin dose titration system using a SMS

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Insulin Dose Titration System in Diabetic Patients Using a Short Messaging Service Automatically Produced by a Knowledge Matrix
Study Start Date : November 2007
Primary Completion Date : November 2008
Study Completion Date : December 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: insulin titration by specialized system
Insulin dose titration system by using a SMS automatically produced by a knowledge matrix
Other: Insulin dose titration system using a SMS
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).
Other Name: insulin used in this study = Lantus (insulin glargine)


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948584


Sponsors and Collaborators
Hallym University Medical Center
Investigators
Principal Investigator: Chul Sik Kim, MD, PhD Hallym University Medical Center
More Information

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00948584     History of Changes
Other Study ID Numbers: 2007-I038
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by Hallym University Medical Center:
Diabetes Mellitus, Type 2
Insulin dose titration system

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs