Pre-Gestational DiabetesNCT05662462
Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
A study testing DEXCOM G7 PRO Continuous Glucose Monitor, Patient mHealth app linked to a provider dashboard and Care team coaching for medical and social needs (HUB) in people with Pre-Gestational Diabetes and Type2diabetes, run by Ohio State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic
- What is being tested?
- DEXCOM G7 PRO Continuous Glucose Monitor, Patient mHealth app linked to a provider dashboard and Care team coaching for medical and social needs (HUB)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- pregnant individuals age ≥18 years;
- ≤20 weeks of gestation (specifically, <20+6 weeks);
- diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
- Medicaid insurance;
- English or Spanish speaking;
- cognitively able to complete the study requirements;
Show all 10Show fewer
- consent to all study activities;
- accessible for participation in study activities;
- use a smartphone with internet access;
- Participants must also consent to the study team abstracting information from their electronic health records (EHRs), using CGM for glucose monitoring if randomized to the intervention group, tracking the participants' clinic, hospital, and emergency room visits during the study period, as well as tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application (app), including what activities are used in the mobile application (e.g., recording blood glucose, scheduling appointments, messaging their healthcare providers, accessing educational resources).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
Kartik Venkatesh, MD, PhD, 614-293-2222, Kartik.Venkatesh@osumc.edu
About this study
Official title: ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
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
Read the detailed description
Type 2 diabetes (T2D) in pregnancy increases the risk of adverse outcomes for both the mother and infant. Over 1 in 3 infants born to individuals with T2D will experience an adverse outcome, including large for gestational age at birth, preterm birth, birth trauma, neonatal hypoglycemia, and stillbirth. Strict maternal glycemic control throughout pregnancy is key to optimizing perinatal outcomes. This is possible with insulin pharmacotherapy, vigilant glucose monitoring, lifestyle modifications including diet and exercise, and team-based prenatal care. Medicaid-enrolled pregnant individuals with T2D experience non-medical social needs that limit their ability to achieve glycemic control, including lack of reliable transportation to attend prenatal visits, access to resources to engage in diet and exercise changes, and convenient methods to log self-monitored glucose values and adjust insulin dosing.
A multi-faceted provider-patient based approach is needed with proven strategies to improve glycemic control. We propose "ACHIEVE: Successfully achieving and maintaining euglycemia during pregnancy for type 2 diabetes through technology and coaching." Our intervention is 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. This intervention empowers Medicaid-enrolled pregnant individuals with T2D and their healthcare providers to achieve and maintain glycemic control, improve access to care, and provide patient education and support. Each sub-component of the proposed intervention is grounded in Social Cognitive Theory (SCT), and emphasizes on individuals' skills, knowledge and beliefs, and self-efficacy to achieve glycemic control.
We propose four aims: AIM 1: Develop the tailored ACHIEVE mHealth app and provider dashboard for Medicaid-enrolled pregnant individuals with T2D and their healthcare team through active stakeholder engagement; AIM 2: Conduct an RCT and 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; and AIM 3: Identify multi-level patient and provider barriers and facilitators to satisfaction, engagement, and use of the intervention and its subcomponents. AIM 4: Examine postpartum (i.e. 6-12 months after delivery) diabetes and reproductive health outcomes in both intervention and standard care arms.
- Being tested
- DEXCOM G7 PRO Continuous Glucose Monitor, Patient mHealth app linked to a provider dashboard, Care team coaching for medical and social needs (HUB), Provider dashboard
- Keywords
- mHealth, Pregnancy, Type 2 diabetes, Continuous glucose monitoring, Mobile application, Medicaid, Glycemic control
- Medical subject headings
- Pregnancy in Diabetics, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXCOM G7 PRO Continuous Glucose MonitorDevice
Participants in the intervention arm will be provided with DEXCOM® G7 PRO CGM sensors and transmitters. The Dexcom G7 CGM system is accurate and safe in pregnant individuals with diabetes. Participants will be taught how to place and remove CGM sensors by a trained research nurse, and will be given sensors to change themselves at home every 10 days. Of note, the DEXCOM® G7 PRO can be applied as a patch on the abdomen, arm, or upper buttocks, is well-tolerated in pregnancy, and does not require calibration. Our mHealth app will allow for wireless synchronization with the CGM sensor so that data are seamlessly reported back to the healthcare team.
Patient mHealth app linked to a provider dashboardDevice
The mHealth app is based on our team's prototype intervention developed at our study site. The mHealth app provides diverse functions, including education, reminders, care goals, care pathway recommendations, CGM data and PROs reporting and monitoring, messaging and video conferencing, and a calendar function. Content is based on clinical guidelines for diabetes in pregnancy. Participants will be directed to appropriate resources and online learning to help them navigate the app and its resources. PROs in the mHealth app will be embedded to address health and social needs, and rule-based algorithms will provide tailored care goals, show care pathways, and establish the frequency of elicited PROs.
Care team coaching for medical and social needs (HUB)Behavioural
Also called Healthcare Collaborative of Greater Columbus Central Ohio Pathways HUB and social needs
Participants will be screened at enrollment and throughout the intervention for social needs using a survey adapted from validated instruments, such as the Accountable Health Communities Health-Related Social Needs Screening Tool. The care team will refer participants with affirmative responses to the HUB through the provider dashboard to address social needs (e.g., food insecurity, housing, employment). HUB community health workers will perform comprehensive social needs assessments and connect participants to community resources through "care pathways," a defined action plan addressing patient needs which is recorded and tracked.
Provider dashboardDevice
The ACHIEVE intervention will include a bi-directional dashboard that displays information about individuals, including priority care goals and pathways, and recommendations generated via PROMPT. Healthcare team members can access the dashboard embedded within a portal to modify or update information and close the loop on participant tasks. The dashboard will present recommendations for participant goals and pathways provided by the PROMPT algorithms. Providers can use these recommendations or manually select ones for the participant. Providers can sequence goals and pathways by level of complexity. Both the HUB and the healthcare team can perform ongoing assessments of HUB pathway selections and assess recurring needs through the provider dashboard.
| Study group | Role | What they receive |
|---|---|---|
| ACHIEVE Intervention | Active comparator | 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. Receives: Device: DEXCOM G7 PRO Continuous Glucose Monitor; Device: Patient mHealth app linked to a provider dashboard; Behavioral: Care team coaching for medical and social needs (HUB); Device: Provider dashboard |
| Standard of care | No intervention | Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery
A1c is a blood test that represents the average glucose over the previous three months. Our outcome threshold is slightly higher than the target of <6.0 recently recommended by ADA because: 1) our target population of pregnant individuals includes those with poor glycemic control at enrollment, 2) an aggressive target <6% can result in frequent episodes of hypoglycemia, of particular concern for participants in the standard care arm without CGM, and 3) the frequency of adverse neonatal outcomes are similar with third trimester A1c 6-6.4% vs. <6%. A1c will be assessed once per trimester, consistent with ADA and ACOG guidelines for T2D management in pregnancy, and at delivery. For participants with >1 value in the third trimester, the value closest to delivery will be used. A standard assay will be used for HbA1c. We will evaluate HbA1c as an absolute percentage of total hemoglobin using reference standards per the Diabetes Control and Complications Trial Reference Method.
Measured: From ≤20 weeks of gestation to delivery, an average of 5 months
Secondary outcomes (22)
Large for gestational age at birth
Birthweight >90% for gestational age using a 2017 NCHS reference standard
Measured: At birth
Neonatal hypoglycemia
Any blood glucose <30 mg/dL within 48 hours of delivery
Measured: 48 hours of delivery
NICU admission
NICU admission for any indication
Measured: Delivery admission
Preterm birth <37 weeks
Measured: At birth
Respiratory distress syndrome
Measured: Delivery admission
Percentage of time-in-range (TIR)
Among participants in the intervention arm, we will assess CGM measures of glycemic control. The target range will be between 63 to 140 mg/dL, consistent with the CONCEPTT CGM trial in pregnant individuals with T1D, emerging data in pregnancy, and expert opinion. We will assess TIR as both a continuous and dichotomous measure (≥85%).
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Mean CGM glucose levels during the day and night
Among participants in the intervention arm, we will assess CGM measures of glycemic control.
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Time spent above and below target range
Among participants in the intervention arm, we will assess CGM measures of glycemic control.
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Low and high blood glucose indices
Among participants in the intervention arm, we will assess CGM measures of glycemic control.
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Patient activation measure (PAM)
These outcomes will be measured by survey to capture knowledge, skill, and confidence to manage one's health and health care 13-items, continuous scale measures from 0 to 100. This is a PRO.
Measured: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Patient intervention tool technology engagement
Patient intervention tool technology engagement data will be collected through Log files and will be measured as the number of sessions a participant had with the tool (total and average use for tool and specific functions).
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
The Accountable Health Communities. Health-Related Social Needs Screening Tool
Provider dashboard and HUB data (for intervention group) and EHR referral and chart notes by licensed social worker (standard of care group).
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Blood glucose levels
EHR data and mHealth app (CGM)(for the intervention group) and self-monitored blood glucose (for standard of care group)
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Diabetes Knowledge Questionnaire (DKQ)
Measured through Patient's Diabetes Knowledge Questionnaire. This is a PRO. 24 item scale, continuous measure.
Measured: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Morisky Medication Adherence Scale (MMAS-8)
Adherence will be measured through Medication Adherence Scale. This is a PRO
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Health care utilization
Scheduled prenatal clinic visits, hospitalizations, emergency department visits, obstetric triage visits, and unscheduled clinic visits through EHR. Data will be collected from the electronic health record and patient survey.
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Short Assessment of Health Literacy-Spanish and English (SAHL-S&E)
Health literacy will be measured through eHealth literacy scale and Health literacy scale. This is a PRO. A score between 0 and 14 suggests the examinee has low health literacy.
Measured: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
eHealth literacy scale (eHEALS)
8-item measure of eHealth literacy.
Measured: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Comprehension of education material
Comprehension of education material will be measured through Self-developed survey. This is a PRO.
Measured: 3 times in the first six weeks and then monthly during study participation, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.
Diabetes Distress Scale (DDS)
Diabetes Distress will be measured through the Diabetes Distress Scale. This is a PRO. The DDS is a self-report survey that has 17 items.
Measured: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Self-efficacy for Diabetes
Self-efficacy will be measured through the Diabetes Management Self-Efficacy Scale. This is a PRO. Continuous measure or mean score of 8 items.
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.
Doctor-Patient Communication Scale
The questionnaire contains 15 items with 4 possible answers: no, possibly no, possibly yes, and yes, rated according to a Likert-type scale (1 to 4 points), with score of 4 being the best possible response.
Measured: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start11 Jul 2024
- Primary completionMay 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), DexCom, Inc.
- Responsible party
- Principal investigator, Kartik K Venkatesh, Ohio State University
- Investigators
- Naleef Fareed, PhD, MBA, Principal investigator, Ohio State UniversityJoshua J Joseph, MD, Principal investigator, Ohio State UniversityKartik K Venkatesh, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662462
- Sponsor's protocol ID
- 2022H0399
- Status last verified
- Jun 2026
- First submitted
- 22 Nov 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Venkatesh KK, Joseph JJ, Swoboda C, Strouse R, Hoseus J, Baker C, Summerfield T, Bartholomew A, Buccilla L, Pan X, Sieck C, McAlearney AS, Huerta TR, Fareed N. Multicomponent provider-patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study. BMJ Open. 2023 May 10;13(5):e074657. doi: 10.1136/bmjopen-2023-074657.
PubMed 37164461
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
- ClinicalTrials.gov ID
- NCT05662462
- Acronym / sponsor ID
- 2022H0399
- Keywords
- mHealth, Pregnancy, Type 2 diabetes, Continuous glucose monitoring, Mobile application, Medicaid, Glycemic control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), DexCom, Inc.
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Type 2 diabetes (T2D) in pregnancy increases the risk of adverse outcomes for both the mother and infant. Over 1 in 3 infants born to individuals with T2D will experience an adverse outcome, including large for gestational age at birth, preterm birth, birth trauma, neonatal hypoglycemia, and stillbirth. Strict maternal glycemic control throughout pregnancy is key to optimizing perinatal outcomes. This is possible with insulin pharmacotherapy, vigilant glucose monitoring, lifestyle modifications including diet and exercise, and team-based prenatal care. Medicaid-enrolled pregnant individuals with T2D experience non-medical social needs that limit their ability to achieve glycemic control, including lack of reliable transportation to attend prenatal visits, access to resources to engage in diet and exercise changes, and convenient methods to log self-monitored glucose values and adjust insulin dosing.
A multi-faceted provider-patient based approach is needed with proven strategies to improve glycemic control. We propose "ACHIEVE: Successfully achieving and maintaining euglycemia during pregnancy for type 2 diabetes through technology and coaching." Our intervention is 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. This intervention empowers Medicaid-enrolled pregnant individuals with T2D and their healthcare providers to achieve and maintain glycemic control, improve access to care, and provide patient education and support. Each sub-component of the proposed intervention is grounded in Social Cognitive Theory (SCT), and emphasizes on individuals' skills, knowledge and beliefs, and self-efficacy to achieve glycemic control.
We propose four aims: AIM 1: Develop the tailored ACHIEVE mHealth app and provider dashboard for Medicaid-enrolled pregnant individuals with T2D and their healthcare team through active stakeholder engagement; AIM 2: Conduct an RCT and 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; and AIM 3: Identify multi-level patient and provider barriers and facilitators to satisfaction, engagement, and use of the intervention and its subcomponents. AIM 4: Examine postpartum (i.e. 6-12 months after delivery) diabetes and reproductive health outcomes in both intervention and standard care arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACHIEVE Intervention | Active comparator | Device: DEXCOM G7 PRO Continuous Glucose Monitor, Device: Patient mHealth app linked to a provider dashboard, Behavioral: Care team coaching for medical and social needs (HUB), Device: Provider dashboardThe 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. |
| Standard of care | No intervention | –Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- pregnant individuals age ≥18 years;
- ≤20 weeks of gestation (specifically, <20+6 weeks);
- diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
- Medicaid insurance;
- English or Spanish speaking;
Key exclusion criteria (0 listed)
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 G7 PRO Continuous Glucose MonitorParticipants in the intervention arm will be provided with DEXCOM® G7 PRO CGM sensors and transmitters. The Dexcom G7 CGM system is accurate and safe in pregnant individuals with diabetes. Participants will be taught how to place and remove CGM sensors by a trained research nurse, and will be given sensors to change themselves at home every 10 days. Of note, the DEXCOM® G7 PRO can be applied as a patch on the abdomen, arm, or upper buttocks, is well-tolerated in pregnancy, and does not require calibration. Our mHealth app will allow for wireless synchronization with the CGM sensor so that data are seamlessly reported back to the healthcare team. | Device | ACHIEVE Intervention |
| Patient mHealth app linked to a provider dashboardThe mHealth app is based on our team's prototype intervention developed at our study site. The mHealth app provides diverse functions, including education, reminders, care goals, care pathway recommendations, CGM data and PROs reporting and monitoring, messaging and video conferencing, and a calendar function. Content is based on clinical guidelines for diabetes in pregnancy. Participants will be directed to appropriate resources and online learning to help them navigate the app and its resources. PROs in the mHealth app will be embedded to address health and social needs, and rule-based algorithms will provide tailored care goals, show care pathways, and establish the frequency of elicited PROs. | Device | ACHIEVE Intervention |
| Care team coaching for medical and social needs (HUB)Also: Healthcare Collaborative of Greater Columbus Central Ohio Pathways HUB and social needsParticipants will be screened at enrollment and throughout the intervention for social needs using a survey adapted from validated instruments, such as the Accountable Health Communities Health-Related Social Needs Screening Tool. The care team will refer participants with affirmative responses to the HUB through the provider dashboard to address social needs (e.g., food insecurity, housing, employment). HUB community health workers will perform comprehensive social needs assessments and connect participants to community resources through "care pathways," a defined action plan addressing patient needs which is recorded and tracked. | Behavioural | ACHIEVE Intervention |
| Provider dashboardThe ACHIEVE intervention will include a bi-directional dashboard that displays information about individuals, including priority care goals and pathways, and recommendations generated via PROMPT. Healthcare team members can access the dashboard embedded within a portal to modify or update information and close the loop on participant tasks. The dashboard will present recommendations for participant goals and pathways provided by the PROMPT algorithms. Providers can use these recommendations or manually select ones for the participant. Providers can sequence goals and pathways by level of complexity. Both the HUB and the healthcare team can perform ongoing assessments of HUB pathway selections and assess recurring needs through the provider dashboard. | Device | ACHIEVE Intervention |
Primary outcome
The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery
Time frame: From ≤20 weeks of gestation to delivery, an average of 5 months
A1c is a blood test that represents the average glucose over the previous three months. Our outcome threshold is slightly higher than the target of <6.0 recently recommended by ADA because: 1) our target population of pregnant individuals includes those with poor glycemic control at enrollment, 2) an aggressive target <6% can result in frequent episodes of hypoglycemia, of particular concern for participants in the standard care arm without CGM, and 3) the frequency of adverse neonatal outcomes are similar with third trimester A1c 6-6.4% vs. <6%. A1c will be assessed once per trimester, consistent with ADA and ACOG guidelines for T2D management in pregnancy, and at delivery. For participants with >1 value in the third trimester, the value closest to delivery will be used. A standard assay will be used for HbA1c. We will evaluate HbA1c as an absolute percentage of total hemoglobin using reference standards per the Diabetes Control and Complications Trial Reference Method.
22 secondary outcomes
Large for gestational age at birth
Time frame: At birth
Neonatal hypoglycemia
Time frame: 48 hours of delivery
NICU admission
Time frame: Delivery admission
Preterm birth <37 weeks
Time frame: At birth
Respiratory distress syndrome
Time frame: Delivery admission
Percentage of time-in-range (TIR)
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Mean CGM glucose levels during the day and night
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Time spent above and below target range
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Low and high blood glucose indices
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Patient activation measure (PAM)
Time frame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Patient intervention tool technology engagement
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
The Accountable Health Communities. Health-Related Social Needs Screening Tool
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Blood glucose levels
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Diabetes Knowledge Questionnaire (DKQ)
Time frame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Morisky Medication Adherence Scale (MMAS-8)
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Health care utilization
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Short Assessment of Health Literacy-Spanish and English (SAHL-S&E)
Time frame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
eHealth literacy scale (eHEALS)
Time frame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Comprehension of education material
Time frame: 3 times in the first six weeks and then monthly during study participation, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.
Diabetes Distress Scale (DDS)
Time frame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Self-efficacy for Diabetes
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.
Doctor-Patient Communication Scale
Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 37164461Venkatesh KK, Joseph JJ, Swoboda C, Strouse R, Hoseus J, Baker C, Summerfield T, Bartholomew A, Buccilla L, Pan X, Sieck C, McAlearney AS, Huerta TR, Fareed N. Multicomponent provider-patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study. BMJ Open. 2023 May 10;13(5):e074657. doi: 10.1136/bmjopen-2023-074657.
- Individual participant dataSharing planned: No
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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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXCOM G7 PRO Continuous Glucose Monitor, Patient mHealth app linked to a provider dashboard and Care team coaching for medical and social needs (HUB) in people with Pre-Gestational Diabetes and Type2diabetes, run by Ohio State University at 1 site in United States.
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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kartik Venkatesh, MD, PhD (614-293-2222, kartik.venkatesh@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery (time frame: From ≤20 weeks of gestation to delivery, an average of 5 months). 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 NCT05662462, which also lists 1 linked publication.
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 29 Jun 2026.