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

NCT00948584 | Completed

• 1 other identifier: 2007-I038
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Insulin dose titration system

Outcome Measures

Primary Outcomes (1)

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

  three months

Secondary Outcomes (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.

  three months

Study Arms (1)

insulin titration by specialized system

EXPERIMENTAL

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

Other: Insulin dose titration system using a SMS

Interventions

Insulin dose titration system using a SMS OTHER

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).

Also known as: insulin used in this study = Lantus (insulin glargine)

insulin titration by specialized system

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chul Sik Kim, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 29, 2009
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 29, 2009

Record last verified: 2009-07