Diabetes Mellitus, Type INCT02556554

Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

A study testing Dexcom G4 or G5 Platinum CGM system and Dexcom G4 or G5 Platinum CGM system with Share in people with Diabetes Mellitus, Type I, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Diabetes Mellitus, Type I
What is being tested?: Dexcom G4 or G5 Platinum CGM system and Dexcom G4 or G5 Platinum CGM system with Share
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado
Aurora, Colorado, 80045

Other trials in United States

About this study

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

Read the 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.

Conditions: Diabetes Mellitus, Type I
Being tested: Dexcom G4 or G5 Platinum CGM system, Dexcom G4 or G5 Platinum CGM system with Share
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexcom G4 or G5 Platinum CGM systemDevice
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
Dexcom G4 or G5 Platinum CGM system with ShareDevice
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™

Study groups in NCT02556554
Study group	Role	What they receive
Routine Care	No intervention	Standard of Care in the Pregnancy and Women's Health clinic.
Dexcom G4 Platinum CGM system	Active comparator	An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy. Receives: Device: Dexcom G4 or G5 Platinum CGM system
Dexcom G4 Platinum CGM system with Share™	Active comparator	A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy. Receives: Device: Dexcom G4 or G5 Platinum CGM system with Share

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Glucose Variability
Glucose variability as measured by glucose excursions from CGM
Measured: From first pregnancy visit to delivery
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.
Measured: From first pregnancy visit to delivery

Secondary outcomes (2)

Change in A1C.
Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.
Measured: From first pregnancy visit to delivery
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)
Measured: From first pregnancy visit to delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Aug 2017

First posted22 Sep 2015 (estimated)
Study startAug 2015
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02556554
Sponsor's protocol ID: 15-1006
Status last verified: Jul 2020
First submitted: 11 Sep 2015
Last updated: 21 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 34524020
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.
PubMed 34115946
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.
PubMed 31779476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02556554
Acronym / sponsor ID: 15-1006
Conditions: Diabetes Mellitus, Type I
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: DexCom, Inc.
Study start: Aug 2015
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 22 Sep 2015 (estimated)
Results: Posted 21 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Routine Care	No intervention	–Standard of Care in the Pregnancy and Women's Health clinic.
Dexcom G4 Platinum CGM system	Active comparator	Device: Dexcom G4 or G5 Platinum CGM systemAn intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 Platinum CGM system with Share™	Active comparator	Device: Dexcom G4 or G5 Platinum CGM system with ShareA treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexcom G4 or G5 Platinum CGM systemIntervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy	Device	Dexcom G4 Platinum CGM system
Dexcom G4 or G5 Platinum CGM system with ShareTreatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™	Device	Dexcom G4 Platinum CGM system with Share™

Primary outcome

Changes in Glucose Variability
Time frame: From first pregnancy visit to delivery
Glucose variability as measured by glucose excursions from CGM
Change(s) in Behavior and/or Concerns of Diabetics.
Time frame: From first pregnancy visit to delivery
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.

2 secondary outcomes

Change in A1C.
Time frame: From first pregnancy visit to delivery
Evaluation of Maternal and Fetal Outcomes.
Time frame: From first pregnancy visit to delivery

Results and safety

Results posted to the registry on 21 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Routine Care	8	8
Dexcom G4 Platinum CGM System	14	13
Dexcom G4 Platinum CGM System With Share™	19	15
Followers for Dexcom Alone	12	12
Followers for Dexcom Share	14	14

Primary outcome: Changes in Glucose Variability

Time frame: From first pregnancy visit to delivery. Median (Inter-Quartile Range). Unit: % time spent in range

Measure	Dexcom G4 Platinum CGM System n = 13	Dexcom G4 Platinum CGM System With Share™ n = 15
Time spent <65 mg/dL (1st trimester)	7.5 (4.7 to 9.0)	7.3 (3.6 to 8.2)
Time spent 65-140 mg/dL (1st trimester)	52.8 (46.4 to 73.0)	59.8 (54.5 to 68.7)
Time spent >140 mg/dL (1st trimester)	38.2 (21.7 to 49.0)	35.1 (24.3 to 41.0)
Time spent <65 mg/dL (2nd trimester)	5.0 (3.8 to 7.5)	5.3 (4.0 to 8.4)
Time spent 65-140 mg/dL (2nd trimester)	50.7 (43.6 to 61.8)	56.6 (48.7 to 69.0)
Time spent >140 mg/dL (2nd trimester)	44.2 (27.8 to 51.7)	37.2 (21.9 to 43.1)
Time spent <65 mg/dL (3rd trimester)	4.0 (3.6 to 4.6)	4.5 (3.4 to 6.1)
Time spent 65-140 mg/dL (3rd trimester)	53.5 (42.6 to 59.4)	62.3 (49.9 to 70.4)

Population analysed: CGM metrics among CGM Share and CGM Alone (not among no CGM since they did not use a CGM)

Primary outcome: Change(s) in Behavior and/or Concerns of Diabetics.

Time frame: From first pregnancy visit to delivery. Mean (Standard Deviation). Unit: score on a scale

Measure	Dexcom G4 Platinum CGM System n = 13	Dexcom G4 Platinum CGM System With Share™ n = 15
Behavior score (1st trimester)	28.8 (5.8)	27.9 (3.9)
Worry Score (1st Trimester)	45.1 (14.8)	34.0 (7.2)
Total Score (1st Trimester)	73.8 (14.1)	61.9 (9.4)
Behavior score (2nd trimester)	28.2 (6.9)	28.9 (4.5)
Worry Score (2nd Trimester)	37.5 (12.5)	34.6 (9.7)
Total Score (2nd Trimester)	65.8 (15.4)	63.4 (13.0)
Behavior score (3rd trimester)	28.6 (6.6)	28.2 (4.1)
Worry Score (3rd Trimester)	43.4 (19)	37.4 (7.8)

Population analysed: Hypoglycemia Fear Survey results (higher scores indicate more behavioral changes, worry, or total fear scores). Only prospectively enrolled pregnant women were administered this questionnaire (CGM Alone and CGM Share groups).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexcom G4 Platinum CGM System	3 of 13 (23.1%)	0 of 13 (0%)	0 of 13
Dexcom G4 Platinum CGM System With Share™	4 of 15 (26.7%)	0 of 15 (0%)	0 of 15
Followers of Dexcom G4 Platinum CGM System	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Followers of Dexcom G4 Platinum CGM System With Share™	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34524020Shah 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.
Derived from this study: PubMed 34115946Buschur 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.
Derived from this study: PubMed 31779476Polsky 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarit Polsky, MD, MPH principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Glucose Variability (time frame: From first pregnancy visit to delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556554, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.