Type 1 DiabetesNCT02064023
Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy
A study testing insulin pump and multiple daily insulin injection in people with Type 1 Diabetes and Type 2 Diabetes, run by University of British Columbia at 2 sites in Canada.
Trial summary
This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes, Pregnancy
- What is being tested?
- insulin pump and multiple daily insulin injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2014to 4 Dec 2015
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects are attending the Diabetes Pregnancy Clinic at participating hospitals
- have had type 1 or type 2 diabetes for at least one year
- are in the first trimester or are actively attempting pregnancy
- have a singleton pregnancy
- are receiving intensive insulin therapy
- are judged by clinic staff to be capable of using an insulin pump
Show all 12Show fewer
- are age 19 or older
- are willing to adhere to the study protocol including monitoring blood glucose levels
- are willing to take folic acid before pregnancy and during the first trimester
- are willing to discontinue any medication contraindicated in pregnancy prior to conception
- weigh less than 100 kg (220 lb) prior to becoming pregnant
- use less than 100 units of insulin per day
Who cannot join
- current or previous use of an insulin pump
- use of fertility treatments
- have a multiple pregnancy
- have had children born with major birth defects
- have experienced stillbirth or multiple early pregnancy losses
- have significant diabetes complications or a serious medical issue
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia, V3T 0G9
B.C. Women's Hospital
Vancouver, British Columbia
About this study
Official title: Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy
This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.
Read the detailed description
Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Pregnancy
- Being tested
- insulin pump, multiple daily insulin injection
- Keywords
- insulin pump, CSII, multiple daily injections, MDI, type 1 diabetes, type 2 diabetes, pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin pumpDevice
subjects in the experimental arm will administer insulin using a pump
multiple daily insulin injectionOther
Subjects will continue with usual insulin injections
| Study group | Role | What they receive |
|---|---|---|
| insulin pump | Experimental | subjects will use an insulin pump for the duration of the pregnancy. The intervention is that they will control their diabetes using an insulin pump Receives: Device: insulin pump |
| Multiple Daily Insulin injections | Active comparator | subjects will continue their usual insulin treatment with multiple daily injections of sc insulin Receives: Other: multiple daily insulin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite obstetrical/perinatal endpoint consisting of specific elements (see description)
Composite obstetrical/perinatal endpoint consisting of one or more of pre-eclampsia, primary caesarian section, pre-term delivery, spontaneous abortion, termination for congenital anomaly or chromosomal abnormality, perinatal mortality, large-for-gestational age, shoulder dystocia, birth injury, major congenital anomaly, neonatal hypoglycemia, jaundice requiring phototherapy, or admission to neonatal intensive care nursery.
Measured: Up to 42 weeks
Secondary outcomes (1)
Mean maternal HbA1c during pregnancy
HbA1c will be measured at least every three months to provide information about overall glycemic control
Measured: up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startApr 2014
- Primary completion4 Dec 2015
- Study completion4 Dec 2015
Why it stopped: Some sites withdrew because no contract with insulin pump supplier
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Thompson, University of British Columbia
- Investigators
- David M Thompson, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064023
- Sponsor's protocol ID
- H12-02375
- Status last verified
- Oct 2017
- First submitted
- 3 Feb 2014
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy
- ClinicalTrials.gov ID
- NCT02064023
- Acronym / sponsor ID
- H12-02375
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Pregnancy
- Keywords
- insulin pump, CSII, multiple daily injections, MDI, type 1 diabetes, type 2 diabetes, pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Some sites withdrew because no contract with insulin pump supplier
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 4 Dec 2015 (actual)
- Study completion
- 4 Dec 2015 (actual)
- First posted
- 17 Feb 2014 (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.
This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.
Detailed description
Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin pump | Experimental | Device: insulin pumpsubjects will use an insulin pump for the duration of the pregnancy. The intervention is that they will control their diabetes using an insulin pump |
| Multiple Daily Insulin injections | Active comparator | Other: multiple daily insulin injectionsubjects will continue their usual insulin treatment with multiple daily injections of sc insulin |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- subjects are attending the Diabetes Pregnancy Clinic at participating hospitals
- have had type 1 or type 2 diabetes for at least one year
- are in the first trimester or are actively attempting pregnancy
- have a singleton pregnancy
- are receiving intensive insulin therapy
Key exclusion criteria (6 listed)
- current or previous use of an insulin pump
- use of fertility treatments
- have a multiple pregnancy
- have had children born with major birth defects
- have experienced stillbirth or multiple early pregnancy losses
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 pumpsubjects in the experimental arm will administer insulin using a pump | Device | insulin pump |
| multiple daily insulin injectionSubjects will continue with usual insulin injections | Other | Multiple Daily Insulin injections |
Primary outcome
Composite obstetrical/perinatal endpoint consisting of specific elements (see description)
Time frame: Up to 42 weeks
Composite obstetrical/perinatal endpoint consisting of one or more of pre-eclampsia, primary caesarian section, pre-term delivery, spontaneous abortion, termination for congenital anomaly or chromosomal abnormality, perinatal mortality, large-for-gestational age, shoulder dystocia, birth injury, major congenital anomaly, neonatal hypoglycemia, jaundice requiring phototherapy, or admission to neonatal intensive care nursery.
1 secondary outcome
Mean maternal HbA1c during pregnancy
Time frame: up to 42 weeks
Results and safety
The study was stopped early (reason given: Some sites withdrew because no contract with insulin pump supplier). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
David M Thompson, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin pump and multiple daily insulin injection in people with Type 1 Diabetes and Type 2 Diabetes, run by University of British Columbia at 2 sites in Canada.
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 12 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 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 Canada. 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 was stopped early (reason given: Some sites withdrew because no contract with insulin pump supplier). Results are not available in the source record.
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?
Composite obstetrical/perinatal endpoint consisting of specific elements (see description) (time frame: Up to 42 weeks). 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 30 Oct 2017.