Back to resultsPilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
Primary Purpose
Type 1 Diabetes, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Frequent remote contact between clinic visits.
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes, Pregnancy focused on measuring Type 1 diabetes, Pregnancy, Glycemic variability, Between visit contact
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm, remote contact.
Arm Description
Between visit remote contact.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes is severe hypoglycemia
Severe hypoglycemic events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02315274
Brief Title
Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
Official Title
Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Pregnancy
Keywords
Type 1 diabetes, Pregnancy, Glycemic variability, Between visit contact
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm, remote contact.
Arm Type
Experimental
Arm Description
Between visit remote contact.
Intervention Type
Other
Intervention Name(s)
Frequent remote contact between clinic visits.
Intervention Description
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 Outcome Measure Information:
Title
Glucose variability
Description
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.
Time Frame
Baseline to 9 months
Secondary Outcome Measure Information:
Title
Changes is severe hypoglycemia
Description
Severe hypoglycemic events
Time Frame
up to 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
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