Diabetes During PregnancyNCT01907516
Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
A study testing Cell phone-internet home glucose reporting system and Voicemail home blood glucose reporting in people with Diabetes During Pregnancy and Gestational Diabetes, run by Hawaii Pacific Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes During Pregnancy, Gestational Diabetes
- What is being tested?
- Cell phone-internet home glucose reporting system and Voicemail home blood glucose reporting
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- Age less than 18 year
- Pregnancy >=30 weeks 1 day
- Type I pregestational diabetes
- Inability to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
About this study
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.
Read the 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.
Investigators 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 home blood glucose fingerstick reporting. Compliance was determined by the number of home glucose 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. Study 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.
- Conditions
- Diabetes During Pregnancy, Gestational Diabetes
- Being tested
- Cell phone-internet home glucose reporting system, Voicemail home blood glucose reporting
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell phone-internet home glucose reporting systemDevice
Also called Confidant System
Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
Voicemail home blood glucose reportingBehavioural
Glucose monitoring via standard telephone and fax reporting.
| Study group | Role | What they receive |
|---|---|---|
| Cell phone-internet first | Active comparator | Cell phone-internet home glucose reporting system first Receives: Device: Cell phone-internet home glucose reporting system; Behavioral: Voicemail home blood glucose reporting |
| Voicemail first | Placebo comparator | Voicemail home blood glucose reporting first Receives: Device: Cell phone-internet home glucose reporting system; Behavioral: Voicemail home blood glucose reporting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Subject Satisfaction
Satisfaction was measured with a survey after completing using both reporting methods
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific Health
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaii Medical Service Association, Hookele Personal Health Planners, Kapiolani Medical Center For Women & Children
- Responsible party
- Principal investigator, Marguerite Lisa Bartholomew, MD, Hawaii Pacific Health
- Investigators
- Marguerite L Bartholomew, MD, Principal investigator, John A Burns University of Hawaii School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907516
- Sponsor's protocol ID
- 2009-118
- Status last verified
- May 2015
- First submitted
- 22 Jul 2013
- Last updated
- 3 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16390512
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
- ClinicalTrials.gov ID
- NCT01907516
- Acronym / sponsor ID
- 2009-118
- Conditions
- Diabetes During Pregnancy, Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hawaii Pacific HealthUniversity, hospital or other
- Collaborators
- Hawaii Medical Service Association, Hookele Personal Health Planners, Kapiolani Medical Center For Women & Children
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 3 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Investigators 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 home blood glucose fingerstick reporting. Compliance was determined by the number of home glucose 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. Study 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell phone-internet first | Active comparator | Device: Cell phone-internet home glucose reporting system, Behavioral: Voicemail home blood glucose reportingCell phone-internet home glucose reporting system first |
| Voicemail first | Placebo comparator | Device: Cell phone-internet home glucose reporting system, Behavioral: Voicemail home blood glucose reportingVoicemail home blood glucose reporting first |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (4 listed)
- Age less than 18 year
- Pregnancy >=30 weeks 1 day
- Type I pregestational diabetes
- Inability to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell phone-internet home glucose reporting systemAlso: Confidant SystemGlucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector. | Device | Cell phone-internet first, Voicemail first |
| Voicemail home blood glucose reportingGlucose monitoring via standard telephone and fax reporting. | Behavioural | Cell phone-internet first, Voicemail first |
Primary outcome
Compliance With Home Blood Glucose Reporting
Time frame: 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.
1 secondary outcome
Subject Satisfaction
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16390512Jackson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marguerite L Bartholomew, MD principal investigator
John A Burns University of Hawaii School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell phone-internet home glucose reporting system and Voicemail home blood glucose reporting in people with Diabetes During Pregnancy and Gestational Diabetes, run by Hawaii Pacific Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance With Home Blood Glucose Reporting (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.