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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02315274
Enrollment
12
Registered
2014-12-11
Start date
2014-06-30
Completion date
2019-01-31
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes, Pregnancy

Keywords

Type 1 diabetes, Pregnancy, Glycemic variability, Between visit contact

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.

Interventions

OTHERFrequent 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Glucose variabilityBaseline to 9 monthsGlucose 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

MeasureTime frameDescription
Changes is severe hypoglycemiaup to 9 monthsSevere hypoglycemic events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026