Diabetes MellitusNCT00774124
Improving Outcomes in Underserved Women With GDM
A study testing telemonitoring in people with Diabetes Mellitus and Pregnancy, run by Temple University at 2 sites in United States.
Trial summary
Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes Mellitus, Pregnancy
- What is being tested?
- telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of GDM
- 33 or less weeks gestation
Who cannot join
- multiple gestations
- history of glucose intolerance outside of pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Tallahassee Memorial Diabetes Center
Tallahassee, Florida, 32308
About this study
Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.
Read the detailed description
Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.
- Conditions
- Diabetes Mellitus, Pregnancy
- Being tested
- telemonitoring, Standard of care
- Keywords
- GDM, pregnancy, macrosomia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemonitoringOther
Women will transmit their blood glucose levels, fetal movement counts, and insulin doses via the Internet and/or IVR system at least three times per week
Standard of careOther
Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.
| Study group | Role | What they receive |
|---|---|---|
| 1 Telemedicine | Experimental | Usual care plus telemonitoring Receives: Other: telemonitoring |
| 2 Standard of Care | Active comparator | Standard of care - women will monitor and record blood glucose levels four times a day. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal blood glucose control
Measured: 3 to 9 months
Secondary outcomes (1)
infant birthweight
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Carol J Homko, RN, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774124
- Sponsor's protocol ID
- 071694
- Other IDs
- 1R21DK071694
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2008
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Homko CJ, Santamore WP, Whiteman V, Bower M, Berger P, Geifman-Holtzman O, Bove AA. Use of an internet-based telemedicine system to manage underserved women with gestational diabetes mellitus. Diabetes Technol Ther. 2007 Jun;9(3):297-306. doi: 10.1089/dia.2006.0034.
PubMed 17561800
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Underserved Women With GDM
- ClinicalTrials.gov ID
- NCT00774124
- Acronym / sponsor ID
- 071694
- Conditions
- Diabetes Mellitus, Pregnancy
- Keywords
- GDM, pregnancy, macrosomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.
Detailed description
Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Telemedicine | Experimental | Other: telemonitoringUsual care plus telemonitoring |
| 2 Standard of Care | Active comparator | Other: Standard of careStandard of care - women will monitor and record blood glucose levels four times a day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- diagnosis of GDM
- 33 or less weeks gestation
Key exclusion criteria (2 listed)
- multiple gestations
- history of glucose intolerance outside of pregnancy
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 |
|---|---|---|
| telemonitoringWomen will transmit their blood glucose levels, fetal movement counts, and insulin doses via the Internet and/or IVR system at least three times per week | Other | 1 Telemedicine |
| Standard of careHealth data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits. | Other | 2 Standard of Care |
Primary outcome
maternal blood glucose control
Time frame: 3 to 9 months
1 secondary outcome
infant birthweight
Time frame: at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Background: PubMed 17561800Homko CJ, Santamore WP, Whiteman V, Bower M, Berger P, Geifman-Holtzman O, Bove AA. Use of an internet-based telemedicine system to manage underserved women with gestational diabetes mellitus. Diabetes Technol Ther. 2007 Jun;9(3):297-306. doi: 10.1089/dia.2006.0034.
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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.
Carol J Homko, RN, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemonitoring in people with Diabetes Mellitus and Pregnancy, run by Temple University at 2 sites 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 2 inclusion and 2 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maternal blood glucose control (time frame: 3 to 9 months). 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 NCT00774124, 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 20 Oct 2017.