Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
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|ClinicalTrials.gov Identifier: NCT02315274|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 6, 2019
Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes, Pregnancy||Other: Frequent remote contact between clinic visits.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
Experimental: Single arm, remote contact.
Between visit remote contact.
Other: 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.
- 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.
- Changes is severe hypoglycemia [ Time Frame: up to 9 months ]Severe hypoglycemic events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315274
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|