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OpenTrials
Completed

NCT Number: NCT02315274

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

Hypothesis:

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

Completed

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Key information

Conditions

Type 1 Diabetes, Pregnancy Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  1. Changes is severe hypoglycemia

    Time frame: up to 9 months

    Severe hypoglycemic events

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2014
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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