Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

Diabetes Mellitus, Type I Clinical Trial

Official title:

A Single-center, Prospective, 'Open-label,' Investigator-initiated Pilot Study Evaluating the Role of Continuous Glucose Monitor (CGM) Use Either Alone or With Remote Monitoring Capabilities in Pregnancy Associated With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556554
• Other study ID #: 15-1006
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.

Description:

A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable subjects to share CGM data with family and friends (whom the investigators will call "followers" in this protocol) among women with T1DM associated with pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent before any study-related activities

• Female aged 18 years and older

• T1D duration >1 year

• Pregnancy with confirmation of gestational age 13 weeks or less

• Willingness to routinely practice at least 3-7 blood glucose measurements per day

• Using MDI or CSII therapy

• Willingness to provide an A1C level

• Ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy

• Able to speak, read, and write English

Exclusion Criteria

• Extensive skin changes/diseases that inhibit wearing a sensor on normal skin

• Known allergy to adhesives

• Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type I

Intervention

Device:
• Dexcom G4 or G5 Platinum CGM system
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
• Dexcom G4 or G5 Platinum CGM system with Share
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Glucose Variability	Glucose variability as measured by glucose excursions from CGM	From first pregnancy visit to delivery
Primary	Change(s) in Behavior and/or Concerns of Diabetics.	Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome.	From first pregnancy visit to delivery
Secondary	Change in A1C.	Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.	From first pregnancy visit to delivery
Secondary	Evaluation of Maternal and Fetal Outcomes.	Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures)	From first pregnancy visit to delivery