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

Mayo Clinic12 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes, Pregnancy

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes Inclusion Criteria: * 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: * 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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 9 months

Secondary Outcomes

Changes is severe hypoglycemia

Severe hypoglycemic events

Time frame: up to 9 months

Data from ClinicalTrials.gov

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