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

Study Overview
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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.

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

Conditions
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Type 1 Diabetes, Pregnancy

Intervention / Treatment
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* Other: Frequent remote contact between clinic visits.


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm, remote contact.<br>Between visit remote contact. | Other: Frequent remote contact between clinic visits.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes is severe hypoglycemia | Severe hypoglycemic events | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Pregnancy, Glycemic variability, Between visit contact