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

Not Applicable

Completed

• Conditions: Type 1 Diabetes, Pregnancy
• Interventions: Other: Frequent remote contact between clinic visits.

• 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

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

Arm && Interventions

Group	Intervention	Description
Single arm, remote contact.	Frequent remote contact between clinic visits.	Between visit remote contact.

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