Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

This study has been completed.
Sponsor:
Collaborators:
Hawaii Medical Service Association
Hookele Personal Health Planners
Kapiolani Medical Center For Women & Children
Information provided by (Responsible Party):
Marguerite Lisa Bartholomew, MD, Hawaii Pacific Health
ClinicalTrials.gov Identifier:
NCT01907516
First received: July 22, 2013
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes During Pregnancy
Gestational Diabetes
Device: Cell phone-internet home glucose reporting system
Behavioral: Voicemail home blood glucose reporting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Resource links provided by NLM:


Further study details as provided by Hawaii Pacific Health:

Primary Outcome Measures:
  • Compliance with home blood glucose reporting [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Compliance was determined by the number of home blood glucose determinations reported / expected (%).


Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Satisfaction was measured with a survey after completing using both reporting methods


Enrollment: 100
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cell phone-internet home glucose reporting system first
Cell phone-internet home glucose reporting system first
Device: Cell phone-internet home glucose reporting system
Other Name: Confidant System
Behavioral: Voicemail home blood glucose reporting
Placebo Comparator: Voicemail home blood glucose reporting first
Voicemail home blood glucose reporting first
Device: Cell phone-internet home glucose reporting system
Other Name: Confidant System
Behavioral: Voicemail home blood glucose reporting

Detailed Description:

Control of blood glucose levels is beneficial during pregnancy, however, the ability to effectively monitor patient's blood glucose levels is challenging and time consuming for patients and care providers. Patients must keep track of their own glucose levels and take the initiative to check blood glucose multiple times per day. Traditionally, patients record their glucose levels in a logbook, which they bring with them during an office visit or use to report their glucose levels over the phone. Non compliance and factitious reporting are not uncommon. Obstetricians and or diabetes program staff spend hours communicating with patients to obtain and record glucose values therefore alternatives to phone calls are needed.

We performed a prospective randomized cross over study comparing a conventional voicemail (control) system for home glucose reporting with a cell phone/internet reporting system (Confidant). The primary outcome measure was compliance with fingerstick blood glucose reporting. Compliance was determined by the number of fingersticks reported / expected (%). The secondary outcome was patient satisfaction. Subjects were participants in the Kapiolani Medical Center for Women and Children's diabetes in pregnancy program known as "A Sweeter Choice". IRB approval was obtained before starting the study and all subjects received informed consent. The study was funded by Hawai'i Medical Service Association, a medical insurance company in Hawaii. The Confidant equipment was supplied by Hookele Personal Health Planners, LLC. None of the Ho'okele or Hawaii Medical Service Association staff were involved in data collection or analysis. Subjects were randomized to Confidant or the control system at the entry into the diabetes program during consultation with the Maternal Fetal Medicine physician. After randomization, subjects performed the assigned monitoring system for 3 weeks. After three weeks, they switched to the other monitoring system. A satisfaction survey was completed after three weeks on the second system was completed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-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.

Exclusion Criteria:

  • Age less than 18 year
  • Pregnancy >=30 weeks 1 day
  • Type I pregestational diabetes
  • Inability to speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907516

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Sponsors and Collaborators
Hawaii Pacific Health
Hawaii Medical Service Association
Hookele Personal Health Planners
Kapiolani Medical Center For Women & Children
Investigators
Principal Investigator: Marguerite L Bartholomew, MD John A Burns University of Hawaii School of Medicine
  More Information

Publications:
Responsible Party: Marguerite Lisa Bartholomew, MD, Physician, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT01907516     History of Changes
Other Study ID Numbers: 2009-118
Study First Received: July 22, 2013
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Pregnancy in Diabetics
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 28, 2014