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

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
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
NCT ID
NCT00948584
First Posted
July 27, 2009
Last Updated
July 28, 2009
Sponsor
Hallym University Medical Center
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
Learn more about this trial
Insulin Dose Titration System Using a Short Messaging Service (SMS) Automatically Produced by a Knowledge Matrix
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