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Trial record 1 of 1 for:    NCT01950676
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Feasibility of Using a Smart Phone Application for Self-titration of Insulin on Glycemic Control in Patients With T2DM

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ClinicalTrials.gov Identifier: NCT01950676
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : January 11, 2016
Sponsor:
Collaborators:
Duke-NUS Graduate Medical School
Singapore General Hospital
Information provided by (Responsible Party):
Dr. David Matchar, National University, Singapore

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Smart phone application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility of Using a Smart Phone Application for Self-titration of Insulin on Glycemic Control in Patients With Type 2 Diabetes
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Individuals in the control group will not use the smart phone application
Experimental: Intervention
Individuals in the intervention group will use the smart phone application in insulin titration
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.




Primary Outcome Measures :
  1. Change in glycemic control (HbA1c) between the intervention and the control group [ Time Frame: Baseline and Week 24 ]

Secondary Outcome Measures :
  1. Frequency of hypoglycemic episodes [ Time Frame: up to Week 24 ]
  2. Treatment satisfaction as measured by DTSCs and DTSQc [ Time Frame: Baseline and Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin naïve patient with T2DM
  • Between 30 and 70 years of age
  • HbA1c ≥7.5%
  • Ability and willingness to inject once-a-day long-acting insulin
  • Ability and willingness to perform self-monitoring of blood glucose (SMBG)
  • Access to a smart phone Exclusion Criteria:

Exclusion Criteria:

  • Hypoglycemia unawareness
  • Severe renal impairment (i.e., eGFR <30 ml/min)
  • Corticosteroid use
  • Serious disease with life expectancy <1 year
  • Pregnancy
  • Patients with labile medical conditions that would predispose them to poor insulin control (e.g., frequent or recurrent infections)
  • Patients with psychological and social issues that would prevent continuous injection of insulin and monitoring of blood glucose (e.g., major depressive disorder, homelessness)

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): NCT01950676


Locations
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Singapore
Singapore General Hospital Department of Endocrinology
Singapore, Singapore, 169608
Sponsors and Collaborators
National University, Singapore
Duke-NUS Graduate Medical School
Singapore General Hospital
Investigators
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Principal Investigator: David Matchar, MD Duke-NUS Graduate Medical School
Principal Investigator: Yong Mong Bee, MBBS Singapore General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. David Matchar, Professor and Director of the Program in Health Services and Systems Research, Duke-NUS Graduate Medical School Singapore, National University, Singapore
ClinicalTrials.gov Identifier: NCT01950676     History of Changes
Other Study ID Numbers: Duke-NUS-TIDR/2012/0004
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

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