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

Mayo Clinic

Status: Completed

Conditions: Type 1 Diabetes, Pregnancy

Treatments: Other: Frequent remote contact between clinic visits.

Study type: Interventional

Funder types: Other

Identifiers

NCT02315274

14-003219

Details and patient eligibility

About

Hypothesis:

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

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single arm, remote contact.

Experimental group

Description:

Between visit remote contact.

Treatment:

Other: Frequent remote contact between clinic visits.