Clinical trial NCT02556554: Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type I
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2015-09-22
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Changes in Glucose Variability
timeFrame: From first pregnancy visit to delivery
measure: Change(s) in Behavior and/or Concerns of Diabetics.
timeFrame: From first pregnancy visit to delivery
Secondary outcomes:
measure: Change in A1C.
timeFrame: From first pregnancy visit to delivery
measure: Evaluation of Maternal and Fetal Outcomes.
timeFrame: From first pregnancy visit to delivery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarit Polsky, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah VN, Snell-Bergeon JK, Demmitt JK, Joshee P, Garcetti R, Pyle L, Polsky S. Relationship Between Time-in-Range, HbA1c, and the Glucose Management Indicator in Pregnancies Complicated by Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):783-790. doi: 10.1089/dia.2021.0093. Epub 2021 Nov 3.
citation: Buschur EO, Campbell K, Pyle L, Garcetti R, Joshee P, Demmitt JK, Snell-Bergeon JK, Polsky S. Exploratory Analysis of Glycemic Control and Variability Over Gestation Among Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Nov;23(11):768-772. doi: 10.1089/dia.2021.0138.
citation: Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous Glucose Monitor Use With Remote Monitoring Reduces Fear of Hypoglycemia in Pregnant Women With Type 1 Diabetes: A Pilot Study. J Diabetes Sci Technol. 2020 Jan;14(1):191-192. doi: 10.1177/1932296819890864. Epub 2019 Nov 28. No abstract available.