Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes

NCT ID: NCT02315274

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-01-31

Brief Summary

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Hypothesis:

Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.

Detailed Description

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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

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Type 1 Diabetes, Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm, remote contact.

Between visit remote contact.

Group Type EXPERIMENTAL

Frequent remote contact between clinic visits.

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Yogish C. Kudva

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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14-003219

Identifier Type: -

Identifier Source: org_study_id

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