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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes, Pregnancy
• Intervention / Treatment: Other: Frequent remote contact between clinic visits.

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose variability	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.	Baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes is severe hypoglycemia	Severe hypoglycemic events	up to 9 months

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy; Type 1 diabetes; Glycemic variability; Between visit contact
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 14-003219