NCT01950676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

September 22, 2013

Last Update Submit

January 7, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in glycemic control (HbA1c) between the intervention and the control group

    Baseline and Week 24

Secondary Outcomes (2)

  • Frequency of hypoglycemic episodes

    up to Week 24

  • Treatment satisfaction as measured by DTSCs and DTSQc

    Baseline and Week 24

Study Arms (2)

Control

NO INTERVENTION

Individuals in the control group will not use the smart phone application

Intervention

EXPERIMENTAL

Individuals in the intervention group will use the smart phone application in insulin titration

Device: Smart phone application

Interventions

Smart phone applicationDEVICE

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.

Intervention

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital Department of Endocrinology

Singapore, 169608, Singapore

Location

Related Publications (1)

  • Bee YM, Batcagan-Abueg AP, Chei CL, Do YK, Haaland B, Goh SY, Lee PC, Chiam PP, Ho ET, Matchar DB. A Smartphone Application to Deliver a Treat-to-Target Insulin Titration Algorithm in Insulin-Naive Patients With Type 2 Diabetes: A Pilot Randomized Controlled Trial. Diabetes Care. 2016 Oct;39(10):e174-6. doi: 10.2337/dc16-0419. Epub 2016 Aug 9. No abstract available.

    PMID: 27506223DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Matchar, MD

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

  • Yong Mong Bee, MBBS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of the Program in Health Services and Systems Research, Duke-NUS Graduate Medical School Singapore

Study Record Dates

First Submitted

September 22, 2013

First Posted

September 25, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

SG(1)