Trial Outcomes & Findings for Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology (NCT NCT01907516)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

6 weeks

Results posted on

2015-06-03

Participant Flow

Subjects were participants in the Kapiolani Medical Center for Women and Children's (KMCWC) diabetes in pregnancy program known as "A Sweeter Choice". Subjects were enrolled between February 4, 2009 and 3/11/2010.

Participant milestones

Participant milestones
Measure	Cell Phone-internet First, Then Voicemail Cell phone-internet home glucose reporting system first, then voicemail	Voicemail First, Then Cell Phone-internet Voicemail home blood glucose reporting first, then cell phone-internet
First Intervention (3 Weeks) STARTED	50	50
First Intervention (3 Weeks) COMPLETED	40	34
First Intervention (3 Weeks) NOT COMPLETED	10	16
Second Intervention (3 Weeks) STARTED	40	34
Second Intervention (3 Weeks) COMPLETED	40	34
Second Intervention (3 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cell Phone-internet First, Then Voicemail Cell phone-internet home glucose reporting system first, then voicemail	Voicemail First, Then Cell Phone-internet Voicemail home blood glucose reporting first, then cell phone-internet
First Intervention (3 Weeks) Withdrawal by Subject	5	9
First Intervention (3 Weeks) Lost to Follow-up	1	3
First Intervention (3 Weeks) Delivered before second arm	3	4
First Intervention (3 Weeks) Developed DKA during study	1	0

Baseline Characteristics

Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cell Phone-internet First, the Voicemail n=50 Participants Cell phone-internet home glucose reporting system first	Voicemail First, Then Cell Phone-internet n=50 Participants Voicemail home blood glucose reporting first	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.79 years STANDARD_DEVIATION 4.94 • n=5 Participants	32.5 years STANDARD_DEVIATION 5.76 • n=7 Participants	33.12 years STANDARD_DEVIATION 5.37 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Used Confidant Method n=74 Participants Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting	Used Voicemail Method n=74 Participants Voicemail first, then cell phone-internet home glucose monitoring system
Compliance With Home Blood Glucose Reporting	89.3 percentage of expected glucose tests	87.6 percentage of expected glucose tests

SECONDARY outcome

Timeframe: 6 weeks

Satisfaction was measured with a survey after completing using both reporting methods

Outcome measures

Outcome measures
Measure	Used Confidant Method n=74 Participants Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting	Used Voicemail Method Voicemail first, then cell phone-internet home glucose monitoring system
Subject Satisfaction	67 percentage of participants	—

Adverse Events

Cell Phone-internet First, Then Voicemail

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Voicemail First, Then Cell Phone-internet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marguerite Lisa Bartholomew MD

John A Burns School of Medicine / University of Hawaii Dept of Obstetrics and Gynecology

Phone: 808-983-6761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place