N/A
N=67
Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy
Diabetes Mellitus, Type I
Bottom Line
View on ClinicalTrials.gov: NCT02556554 ↗Enrolled (actual)
67
Serious AEs
13.0%
Results posted
Jul 2020
Primary outcome: Primary: Changes in Glucose Variability — 7.5; 7.3; 52.8; 59.8 % time spent in range
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexcom G4 or G5 Platinum CGM system (Device); Dexcom G4 or G5 Platinum CGM system with Share (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Glucose Variability |
7.5; 7.3; 52.8; 59.8; 38.2; 35.1 | — |
| PRIMARY Change(s) in Behavior and/or Concerns of Diabetics. |
28.8; 27.9; 45.1; 34.0; 73.8; 61.9 | — |
| SECONDARY Change in A1C. |
6.85; 6.84; 6.19 | — |
| SECONDARY Evaluation of Maternal and Fetal Outcomes. |
8; 13; 4; 4; 7; 4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02556554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.