Type 1 Diabetes, PregnancyNCT02315274
Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
A study testing Frequent remote contact between clinic visits. in people with Type 1 Diabetes, Pregnancy, run by Mayo Clinic at 1 site in United States.
Trial summary
Hypothesis: Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes, Pregnancy
- What is being tested?
- Frequent remote contact between clinic visits.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2019
- 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
- Adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes
- Female with type 1 diabetes and pregnancy
- EDD prior to November 15, 2014
- 18 years of age and older
- On insulin pump or multiple daily injection insulin program
- Signed patient consent form
Who cannot join
- Female with type 1 diabetes and pregnancy under age 18 or older than age 45
- Female with type 2 diabetes or gestational diabetes and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.
Hypothesis:
Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.
Read the detailed description
Patient will have weekly contact through the Mayo Patient On-line Services to send in their blood glucose readings and to receive recommendations back regarding insulin dose changes. Information will be analyzed regarding the magnitude of change in insulin dosing and in glycemic variability.
- Conditions
- Type 1 Diabetes, Pregnancy
- Being tested
- Frequent remote contact between clinic visits.
- Keywords
- Type 1 diabetes, Pregnancy, Glycemic variability, Between visit contact
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent remote contact between clinic visits.Other
Subjects will upload diabetes device data onto websites. Website data will be reviewed by study team who will provide feedback to patients without clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Single arm, remote contact. | Experimental | Between visit remote contact. Receives: Other: Frequent remote contact between clinic visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability
Glucose variability represented by multiple measures including mean plasma glucose with standard deviation, high blood glucose index, low blood glucose index and average daily risk range.
Measured: Baseline to 9 months
Secondary outcomes (1)
Changes is severe hypoglycemia
Severe hypoglycemic events
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes, PregnancyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yogish C. Kudva, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315274
- Sponsor's protocol ID
- 14-003219
- Status last verified
- Mar 2019
- First submitted
- 9 Dec 2014
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.
- ClinicalTrials.gov ID
- NCT02315274
- Acronym / sponsor ID
- 14-003219
- Conditions
- Type 1 Diabetes, Pregnancy
- Keywords
- Type 1 diabetes, Pregnancy, Glycemic variability, Between visit contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 Dec 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.
Hypothesis:
Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.
Detailed description
Patient will have weekly contact through the Mayo Patient On-line Services to send in their blood glucose readings and to receive recommendations back regarding insulin dose changes. Information will be analyzed regarding the magnitude of change in insulin dosing and in glycemic variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Single arm, remote contact. | Experimental | Other: Frequent remote contact between clinic visits.Between visit remote contact. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes
- Female with type 1 diabetes and pregnancy
- EDD prior to November 15, 2014
- 18 years of age and older
- On insulin pump or multiple daily injection insulin program
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Frequent remote contact between clinic visits.Subjects will upload diabetes device data onto websites. Website data will be reviewed by study team who will provide feedback to patients without clinic visits. | Other | Single arm, remote contact. |
Primary outcome
Glucose variability
Time frame: Baseline to 9 months
Glucose variability represented by multiple measures including mean plasma glucose with standard deviation, high blood glucose index, low blood glucose index and average daily risk range.
1 secondary outcome
Changes is severe hypoglycemia
Time frame: up to 9 months
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 6 Mar 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequent remote contact between clinic visits. in people with Type 1 Diabetes, Pregnancy, run by Mayo Clinic 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 6 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 6 Mar 2019. 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.
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?
Glucose variability (time frame: Baseline to 9 months). 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 6 Mar 2019.