Hyperglycemia in Pregnant Diabetic PatientsPhase 4NCT01875107
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
A Phase 4 study testing insulin pre-treatment in people with Hyperglycemia in Pregnant Diabetic Patients, run by University of Minnesota at 1 site in United States.
Trial summary
Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia in Pregnant Diabetic Patients
- What is being tested?
- insulin pre-treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
- Must be 18 years or older
- Must speak English, Spanish, or Somali
- Patients must receive steroids for fetal lung maturity as part of their hospital course
Who cannot join
- Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
- Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
About this study
Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control.
Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.
- Being tested
- insulin pre-treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin pre-treatmentDrug
insulin pre-treatment of pregnant diabetic patients who receive betamethasone
| Study group | Role | What they receive |
|---|---|---|
| insulin pre-treatment | Experimental | insulin pre-treatment of pregnant diabetic patients who receive betamethasone Receives: Drug: insulin pre-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.
Pregnant diabetic patients admitted to the hospital who receive steroids for fetal lung maturity will have their blood glucose levels checked before and after receiving steroids. Blood glucose levels will be checked fasting and postprandial until the levels are consistently less than 160. This will vary for patients, but will be on average 2 to 14 days.
Measured: number of hospital days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: Time constraints of primary investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia in Pregnant Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelly H Tien,, M.D, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875107
- Sponsor's protocol ID
- 1301M26861
- Status last verified
- Sep 2014
- First submitted
- 3 Jun 2013
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
- ClinicalTrials.gov ID
- NCT01875107
- Acronym / sponsor ID
- 1301M26861
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Time constraints of primary investigator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 11 Jun 2013 (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 assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control.
Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin pre-treatment | Experimental | Drug: insulin pre-treatmentinsulin pre-treatment of pregnant diabetic patients who receive betamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
- Must be 18 years or older
- Must speak English, Spanish, or Somali
- Patients must receive steroids for fetal lung maturity as part of their hospital course
Key exclusion criteria (2 listed)
- Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
- Pregnant women who need to be emergently delivered due to maternal or fetal complications 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 |
|---|---|---|
| insulin pre-treatmentinsulin pre-treatment of pregnant diabetic patients who receive betamethasone | Drug | insulin pre-treatment |
Primary outcome
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.
Time frame: number of hospital days
Pregnant diabetic patients admitted to the hospital who receive steroids for fetal lung maturity will have their blood glucose levels checked before and after receiving steroids. Blood glucose levels will be checked fasting and postprandial until the levels are consistently less than 160. This will vary for patients, but will be on average 2 to 14 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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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.
Shelly H Tien,, M.D principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin pre-treatment in people with Hyperglycemia in Pregnant Diabetic Patients, run by University of Minnesota 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 4 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: withdrawn, as of the sponsor's last update on 12 Sep 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin. (time frame: number of hospital days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2014.