Technology & Coaching for Diabetes in Pregnancy

Overseen By Kartik Venkatesh, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Gestation >20 weeks, No smartphone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

124 Participants Needed

Trial Summary

What is the purpose of this trial?

The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \<6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \<6.5% in the third trimester compared to the standard care group

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a mobile health app and continuous glucose monitoring for diabetes management.

What data supports the effectiveness of this treatment for diabetes in pregnancy?

Research shows that using the Dexcom G6 continuous glucose monitor, which is part of this treatment, can improve glucose management by providing frequent glucose measurements. Additionally, digital health solutions that sync with CGM data, like the BlueStar app, have been shown to enhance self-management behaviors in people with diabetes. ^{1 2 3 4 5}

Is the Dexcom G6 Pro CGM System safe for use in humans?

The Dexcom G6 Pro CGM System has been evaluated for safety and usability, showing improvements in sensor error reduction and ease of use with a new automatic sensor applicator. These enhancements suggest it is generally safe for human use, with increased data availability potentially improving patient experience. ^{2 4 5 6 7}

How does the Technology & Coaching for Diabetes in Pregnancy treatment differ from other treatments?

This treatment is unique because it combines technology, like the Dexcom G6 continuous glucose monitoring system, with coaching to help manage diabetes during pregnancy. The Dexcom G6 provides real-time glucose monitoring, which is more accurate and easier to use than traditional methods, and the coaching component offers personalized support to improve diabetes management. ^{2 4 8 9 10}

Research Team

Naleef Fareed, PhD, MBA

Principal Investigator

Ohio State University

Joshua J Joseph, MD

Principal Investigator

Ohio State University

Kartik K Venkatesh, MD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for pregnant individuals over 18 with Type 2 Diabetes, an A1c ≥6.5%, and Medicaid insurance. They must use a smartphone, speak English or Spanish, consent to health record access and study activities including using a CGM device if assigned. Participants should be ≤20 weeks pregnant and not currently using a CGM.

Inclusion Criteria

Consent to tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application, including specific activities used in the app

Consent to using CGM for glucose monitoring if randomized to the intervention group

Consent to tracking clinic, hospital, and emergency room visits during the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the intervention including a mobile health app, CGM, provider dashboard, and care team coaching, or standard care with prenatal visits and self-monitored blood glucose

26 weeks

Regular prenatal visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum diabetes and reproductive health outcomes

6-12 months postpartum

Treatment Details

Interventions

• Care team coaching for medical and social needs (HUB)
• DEXCOM G6 PRO Continuous Glucose Monitor
• Patient mHealth app linked to a provider dashboard
• Provider dashboard

Trial Overview The trial tests whether a mobile health app linked to continuous glucose monitoring (CGM) and care team coaching can better control blood sugar levels compared to standard prenatal visits and self-monitoring. The goal is achieving hemoglobin A1c <6.5% in the third trimester of pregnancy.

Participant Groups

Group I: ACHIEVE Intervention Active Control 4 Interventions

The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.

Group II: Standard of care Active Control 1 Intervention

Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

In a study of 52 participants with type 2 diabetes over 3 months, the use of the BlueStar digital health solution combined with continuous glucose monitoring led to significant improvements in glycemic control, including a reduction in average glucose levels and time spent above target ranges.

Participants engaged with the app by logging medications, exercise, and food, with 44% regularly logging their medications, indicating that the digital solution not only improved health metrics but also encouraged better self-management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Combined Continuous Glucose Monitoring-Digital Health Solution on Glucose Metrics and Self-Management Behavior for Adults With Type 2 Diabetes: Real-World, Observational Study. Kumbara, AB., Iyer, AK., Green, CR., et al.[2023]

The introduction of a new 'one-button' automatic sensor applicator (ASA) for the Dexcom G6 continuous glucose monitoring system aims to improve user engagement and treatment efficacy by simplifying the application process.

In a usability study with eight certified diabetes educators, the ASA was found to be easier to use compared to the previous sensor applicator, indicating enhanced user experience and potential for improved patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Human Factors Testing on Medical Device Design: Validation of an Automated CGM Sensor Applicator. North, R., Pospisil, C., Clukey, RJ., et al.[2020]

In a study involving 34 adults with type 1 diabetes, the Guardian, Navigator, and Glucoday continuous glucose monitors (CGMs) showed comparable numerical accuracy, particularly excelling in hypoglycemic conditions, while the DexCom had significantly larger numerical errors.

Clinical accuracy during euglycemia was high for all CGMs, but the Navigator and Glucoday performed better in detecting hypoglycemia, indicating their potential for better patient safety in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. Kovatchev, B., Anderson, S., Heinemann, L., et al.[2022]

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.

The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]

In a study involving 12 patients with type 1 diabetes, the Abbott FreeStyle Libre glucose monitoring system showed the best sensor performance, meeting ISO criteria 73.2% of the time, compared to 56.1% for Dexcom and 52.0% for Medtronic.

All glucose monitoring systems performed less accurately during hypoglycemia, indicating a potential safety concern for patients when blood sugar levels drop too low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes. Aberer, F., Hajnsek, M., Rumpler, M., et al.[2022]

The FDA is considering a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system, which would allow users to make insulin dosing decisions based solely on CGM data without needing confirmatory blood glucose tests.

If approved, this change could enhance diabetes management by providing real-time glucose readings every 5 minutes, along with alerts and trending information, potentially reducing the risk of hypoglycemia and improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation Catches Up to Reality. Edelman, SV.[2019]

The Dexcom G6 real-time continuous glucose monitoring (RT-CGM) system significantly improves glycemic control in adults with type 1 diabetes, showing a projected HbA1c reduction of 1.0% compared to 0.4% with standard blood glucose monitoring (SMBG).

Despite higher lifetime costs associated with RT-CGM (CAD 35,353 more than SMBG), it provides substantial quality of life benefits and is considered cost-effective, with an incremental cost-effectiveness ratio of CAD 16,931 per quality-adjusted life year (QALY) gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. Roze, S., Isitt, JJ., Smith-Palmer, J., et al.[2022]

The Dexcom G6 continuous glucose monitoring system demonstrated high accuracy in pregnant women with diabetes, with 92.5% of CGM values falling within ±20% of reference blood glucose values, indicating reliable performance across different sensor wear sites.

The study found no significant device-related adverse events, and skin reactions at insertion sites were either absent or minor, highlighting the safety of the Dexcom G6 system for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Castorino, K., Polsky, S., O'Malley, G., et al.[2021]

The introduction of cellular-enabled glucometers in a telemedicine diabetes program for insulin-requiring pregnant women led to improved maternal glucose control, with a significant reduction in HbA1c levels at delivery (5.8% vs 6.3% for standard glucometer users).

Women with initially poor glucose control (HbA1c >6.5%) benefited the most, showing a greater decrease in HbA1c levels when using cellular-enabled glucometers, highlighting their effectiveness in managing diabetes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular-Enabled Glucometers and Maternal Glucose Control: A Quality Improvement Initiative. Wernimont, SA., Sheng, JS., Fleener, D., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Impact of a Combined Continuous Glucose Monitoring-Digital Health Solution on Glucose Metrics and Self-Management Behavior for Adults With Type 2 Diabetes: Real-World, Observational Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Human Factors Testing on Medical Device Design: Validation of an Automated CGM Sensor Applicator. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Regulation Catches Up to Reality. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cellular-Enabled Glucometers and Maternal Glucose Control: A Quality Improvement Initiative. [2023]