N/A
N=16
AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
Type2Diabetes · Pregnancy in Diabetic
Bottom Line
View on ClinicalTrials.gov: NCT05370612 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period — 8; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexcom G6 CGM (Device); Participant Finger Stick Glucose Monitoring (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period |
8; 8 | — |
| PRIMARY Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management |
2.5; 2.8; 2.6; 2.1; 3.5; 2.5 | — |
| PRIMARY Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range |
64; 65; 72; 55 | — |
| SECONDARY Number of Participants With Cesarean Delivery |
5; 7 | — |
| SECONDARY Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester |
-0.2; 0.0 | — |
| SECONDARY Percentage of Time Spent in Hyperglycemic Range |
11; 22; 16; 22 | — |
| SECONDARY Percentage of Time Spent in Hypoglycemic Range |
1; 2; 0; 1 | — |
| SECONDARY Rates of Gestational Hypertension |
3; 0 | — |
| SECONDARY Rates of Preeclampsia |
2; 1 | — |
| SECONDARY Rates of Polyhydramnios |
1; 0 | — |
| SECONDARY Incidence of Neonatal Hypoglycemia |
2; 3 | — |
| SECONDARY Rates of Fetal Macrosomia |
1; 1 | — |
| SECONDARY Rates of NICU Admission |
3; 2 | — |
| SECONDARY Rates of Spontaneous Preterm Delivery |
1; 1 | — |
| SECONDARY Satisfaction and Quality of Life Survey Scores (5-point Likert Scale) |
35.2; 34.8; 27.6; 35.2; 29.6; 38.3 | — |
| SECONDARY Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings |
7; 0; 1; 3; 3; 0 | — |
| SECONDARY Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring |
3; 6; 1; 6; 4; 0 | — |
| SECONDARY Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes? |
3.2; 2.6; 1.7; 2.2; 2.6; 3.0 | — |
| SECONDARY Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level? |
2.5; 2.6; 1.5; 2.4; 2.0; 2.5 | — |
| SECONDARY Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks? |
3.4; 2.6; 1.8; 2.4; 2.9; 2.8 | — |
| SECONDARY Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment? |
2.6; 2.0; 1.8; 1.8; 1.9; 2.0 | — |
| SECONDARY Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes? |
3.4; 2.4; 1.7; 2.0; 2.7; 3.2 | — |
Summary
This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years of age at enrollment
- Ability to consent in English
- Gestational age less than or equal to 19 weeks 6 days at enrollment
- Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day
- Diagnosis of Type 2 Diabetes less than or equal to 19 weeks 6 days
- Singleton gestation
Exclusion Criteria
- Age less than 18 years of age at enrollment
- Lack of appropriate dating
- Multiple gestations
- Use of concentrated insulin at enrollment (ie U500)
- Preexisting CGM in place
- Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and inhaled, injectable and oral corticosteroids
- Be unwilling or unable to present to Center for Perinatal Care for visits
Data sourced from ClinicalTrials.gov (NCT05370612). 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.