NCT01907516

Brief Summary

To compare compliance and satisfaction between a traditional method of blood glucose reporting using voicemail (control) and a novel method using cell phone /internet (Confidant) technology in the management of diabetic pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

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

February 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 3, 2015

Completed
Last Updated

June 3, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

July 22, 2013

Results QC Date

September 23, 2013

Last Update Submit

May 29, 2015

Conditions

Diabetes During PregnancyGestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • Compliance With Home Blood Glucose Reporting

    Compliance was calculated as a percentage for each method (Confidant or Voicemail) by dividing the total number of reported glucose readings among all participants by the total number of expected readings (4 daily) over the 6 week study time period. Women with gestational diabetes are instructed to monitor their glucose 4 times per day.

    6 weeks

Secondary Outcomes (1)

  • Subject Satisfaction

    6 weeks

Study Arms (2)

Cell phone-internet first

ACTIVE COMPARATOR

Cell phone-internet home glucose reporting system first

Device: Cell phone-internet home glucose reporting systemBehavioral: Voicemail home blood glucose reporting

Voicemail first

PLACEBO COMPARATOR

Voicemail home blood glucose reporting first

Device: Cell phone-internet home glucose reporting systemBehavioral: Voicemail home blood glucose reporting

Interventions

Cell phone-internet home glucose reporting systemDEVICE

Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.

Also known as: Confidant System
Cell phone-internet firstVoicemail first
Voicemail home blood glucose reportingBEHAVIORAL

Glucose monitoring via standard telephone and fax reporting.

Cell phone-internet firstVoicemail first

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women \>=18 years with gestational diabetes or pregestational Type 2 diabetes referred to the diabetes in pregnancy management program before 30 weeks 1 day gestation.

You may not qualify if:

  • Age less than 18 year
  • Pregnancy \>=30 weeks 1 day
  • Type I pregestational diabetes
  • Inability to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Related Publications (1)

  • Jackson CL, Bolen S, Brancati FL, Batts-Turner ML, Gary TL. A systematic review of interactive computer-assisted technology in diabetes care. Interactive information technology in diabetes care. J Gen Intern Med. 2006 Feb;21(2):105-10. doi: 10.1111/j.1525-1497.2005.00310.x. Epub 2005 Dec 22.

    PMID: 16390512BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Selection bias towards English speaking, educated, and technology savvy women, a 25% drop out rate, a high rate of glucose reporting compliance in the control system, and technical problems when Confidant first started which were quickly resolved.

Results Point of Contact

Title
Marguerite Lisa Bartholomew MD
Organization
John A Burns School of Medicine / University of Hawaii Dept of Obstetrics and Gynecology
mbarthol@hawaii.edu
808-983-6761

Study Officials

  • Marguerite L Bartholomew, MD

    John A Burns University of Hawaii School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 25, 2013

Study Start

February 1, 2009

Primary Completion

August 1, 2010

Study Completion

June 1, 2011

Last Updated

June 3, 2015

Results First Posted

June 3, 2015

Record last verified: 2015-05

Locations

US(1)