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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
Sponsor:
Information provided by (Responsible Party):
Yogish C. Kudva, Mayo Clinic

Brief Summary:

Hypothesis:

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

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.

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes is severe hypoglycemia [ Time Frame: up to 9 months ]
    Severe hypoglycemic events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

Additional Information:
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Responsible Party: Yogish C. Kudva, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02315274     History of Changes
Other Study ID Numbers: 14-003219
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Keywords provided by Yogish C. Kudva, Mayo Clinic:
Type 1 diabetes
Pregnancy
Glycemic variability
Between visit contact

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases