Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
Not Applicable
Completed
- Conditions
- Type 1 Diabetes, Pregnancy
- Registration Number
- NCT02315274
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Glucose variability 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.
- Secondary Outcome Measures
Name Time Method Changes is severe hypoglycemia up to 9 months Severe hypoglycemic events
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mayo Clinic🇺🇸Rochester, Minnesota, United States