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Feasibility of Using a Smart Phone Application for Self-titration of Insulin on Glycemic Control in Patients With T2DM

NCT01950676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-01-11

No results posted yet for this study

Summary

The primary aim of this study is to investigate the feasibility of using a patient-centered smart phone application for insulin self-titration on glycemic control. Over a 18-month period, suboptimally controlled type 2 diabetes mellitus (T2DM) on oral antidiabetic agents, thus requiring insulin treatment patients, will be recruited from the Singapore General Hospital (SGH). Patients randomized to the intervention group will be instructed to self-adjust their insulin dose using a smart phone application designed to guide self-titration; patients randomized to the control group will receive the usual clinical care. The primary outcome measure is change in glycated hemoglobin level (HbA1c), 6 months post-enrollment. The investigators hypothesize that using a smart phone application for insulin self-titration is effective in improving glycemic control in T2DM patients compared with usual care.

Conditions

Interventions

DEVICE

Smart phone application

The smart phone application (Diabetes Pal), will guide patients on self-titration of insulin. Patients will be required to key in the CBG readings into the application. Up-titration of insulin dose will be carried out once every 3 days and the recommended insulin dose will be based on the mean of 3 CBG readings and a pre-specified titration algorithm. The process of using the insulin self-titration application will continue until the patient has reached the target pre-breakfast CBG.

Sponsors & Collaborators

Principal Investigators

  • David Matchar, MD · Duke-NUS Graduate Medical School

  • Yong Mong Bee, MBBS · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950676 on ClinicalTrials.gov