Insulin Dose Titration System Using a Short Messaging Service (SMS) Automatically Produced by a Knowledge Matrix
| Tracking Information | |||||
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| First Received Date ICMJE | July 27, 2009 | ||||
| Last Updated Date | July 28, 2009 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary objective was to compare the mean changes of A1C from baseline to end point between two groups. [ Time Frame: three months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00948584 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Insulin Dose Titration System Using a Short Messaging Service (SMS) Automatically Produced by a Knowledge Matrix | ||||
| Official Title ICMJE | Insulin Dose Titration System in Diabetic Patients Using a Short Messaging Service Automatically Produced by a Knowledge Matrix | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
| Intervention ICMJE | 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) |
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| Study Arm (s) | Experimental: insulin titration by specialized system
Insulin dose titration system by using a SMS automatically produced by a knowledge matrix
Intervention: Other: Insulin dose titration system using a SMS |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00948584 | ||||
| Other Study ID Numbers ICMJE | 2007-I038 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hallym University Medical Center | ||||
| Study Sponsor ICMJE | Hallym University Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hallym University Medical Center | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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