Pregestational DiabetesPhase 4NCT07224893
Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
A Phase 4 study testing Use of insulin glargine once daily and Use of insulin glargine twice daily in people with Pregestational Diabetes and Pregnancy, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregestational Diabetes, Pregnancy
- What is being tested?
- Use of insulin glargine once daily and Use of insulin glargine twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 1 Dec 2027
- Phase
- Phase 4
- 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
- Patients older than 18 years of age;
- The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
- Type II diabetes mellitus requiring insulin;
- The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.
- Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management
Who cannot join
- Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;
- Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;
- Known or suspected fetal anomaly or aneuploidy;
- Prisoners;
- Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
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
Sentara Norfolk General Hospital, Norfolk, Virginia 23507
Norfolk, Virginia, 23507
Marwan Ma'ayeh, 7574467900, maayehmg@odu.edu
About this study
Official title: Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin
The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?
- Conditions
- Pregestational Diabetes, Pregnancy
- Being tested
- Use of insulin glargine once daily, Use of insulin glargine twice daily
- Keywords
- continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of insulin glargine once dailyDrug
Insulin glargine will be used once daily
Use of insulin glargine twice dailyDrug
Insulin glargine will be used twice daily
| Study group | Role | What they receive |
|---|---|---|
| Once-Daily Insulin Glargine | Active comparator | Participants randomized to this arm will take insulin glargine once daily Receives: Drug: Use of insulin glargine once daily |
| Twice-Daily Insulin Glargine | Experimental | Participants randomized to this arm will take insulin glargine twice daily Receives: Drug: Use of insulin glargine twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Time in Range
The mean blood glucose time in range as measured by the continuous glucose monitor
Measured: From Day 7 to Day 14 after study enrollment
Secondary outcomes (31)
Hypertensive disorders of pregnancy
Development of hypertensive disorders of pregnancy
Measured: From time of enrollment until time of delivery, up to 20 weeks following enrollment
Preterm birth <34 weeks
Delivery at less than 34 weeks gestation
Measured: From time of enrollment to 34 weeks gestation
Preterm birth <37 weeks
Delivery prior to 37 weeks gestation
Measured: From time of enrollment until 37 weeks gestation
Spontaneous or Indicated Delivery
Whether delivery was spontaneous or there was an indication for induction or cesarean delivery
Measured: From time of enrollment until time of delivery, up to 20 weeks following enrollment
Operative vaginal delivery
Whether an operative vaginal delivery was indicated
Measured: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Cesarean Delivery
Whether a cesarean delivery was indicated
Measured: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Estimated blood loss
The estimated blood loss during delivery
Measured: Duration of labor, up to 24 hours
Quantitative blood loss
The quantified blood loss during delivery
Measured: Duration of labor, up to 24 hours
Blood transfusion
Whether a blood transfusion was necessary during or following delivery
Measured: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Endometritis
Incidence of endometritis (inflammation of uterine lining)
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Chorioamnionitis
Incidence of chorioamnionitis (placental and amniotic membrane infection)
Measured: From time of enrollment until time of hospital discharge (up to 42 days post-delivery)
Wound infection
Infection of wounds left by labor
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Venous thromboembolism
Incidence of venous thromboembolism
Measured: From time of enrollment to time of hospital discharge (up to 42 days post-delivery)
Massive transfusion and postpartum hemorrhage
Incidence of massive transfusion and postpartum hemorrhage
Measured: From time of enrollment until hospital discharge (up to 42 days post-delivery)
ICU admission
Admission to the ICU
Measured: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Maternal death
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Antepartum death
Fetal death
Measured: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Intrapartum death
Fetal death during labor and delivery
Measured: Duration of labor, up to 24 hours
Neonatal Intubation within 72 hours of birth
Measured: From time of delivery to 72 hours later
Continuous positive airway pressure (CPAP) within 72 hours of birth
Use of CPAP for neonate within 72 hours of birth
Measured: From time of delivery to 72 hours later
High-flow nasal cannula (HFNC) within 72 hours of birth
Measured: From time of delivery to 72 hours later
Cardiopulmonary resuscitation within 72 hours of birth
Measured: From time of delivery to 72 hours later
Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Birthweight
Infant birthweight
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Neonatal encephalopathy
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Seizures
Incidence of neonatal seizures
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Shoulder dystocia
Incidence of shoulder dystocia
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Birth trauma
Incidence of neonatal birth trauma
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Intracranial hemorrhage
Incidence of neonatal intracranial hemorrhage
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
NICU admission
Admission of neonate to the neonatal intensive care unit
Measured: From time of delivery to time of hospital discharge, up to 1 year following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start18 May 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pregestational DiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Ma'ayeh, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224893
- Sponsor's protocol ID
- 25-09-FB-0214
- Status last verified
- May 2026
- First submitted
- 31 Oct 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabbe SG, Calfas J, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies. Elsevier; 2017. doi:10.1016/C2013-0-00408-2
Fishel Bartal M, Ashby Cornthwaite JA, Ghafir D, Ward C, Ortiz G, Louis A, Cornthwaite J, Chauhan SSP, Sibai BM. Time in Range and Pregnancy Outcomes in People with Diabetes Using Continuous Glucose Monitoring. Am J Perinatol. 2023 Apr;40(5):461-466. doi: 10.1055/a-1904-9279. Epub 2022 Jul 20.
PubMed 35858653Jethwani P, Saboo B, Jethwani L, Chawla R, Maheshwari A, Agarwal S, Jaggi S. Use of insulin glargine during pregnancy: A review. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):379-384. doi: 10.1016/j.dsx.2021.01.012. Epub 2021 Jan 22.
PubMed 33540243Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol. 2015 Nov;39(7):512-9. doi: 10.1053/j.semperi.2015.08.003.
PubMed 26452316Eledrisi M, Suleiman NN, Salameh O, Khair Hamad M, Rabadi O, Mohamed A, Al Adawi R, Salam A. Twice-daily insulin glargine for patients with uncontrolled type 2 diabetes mellitus. J Clin Transl Endocrinol. 2018 Dec 11;15:35-36. doi: 10.1016/j.jcte.2018.12.002. eCollection 2019 Mar. No abstract available.
PubMed 30619716Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006 Aug;23(8):879-86. doi: 10.1111/j.1464-5491.2006.01913.x.
PubMed 16911626Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A, Cordoni C, Costa E, Brunetti P, Bolli GB. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000 Dec;49(12):2142-8. doi: 10.2337/diabetes.49.12.2142.
PubMed 11118018Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care. 2000 May;23(5):644-9. doi: 10.2337/diacare.23.5.644.
PubMed 10834424Candido R, Wyne K, Romoli E. A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus. Diabetes Ther. 2018 Jun;9(3):927-949. doi: 10.1007/s13300-018-0422-4. Epub 2018 Apr 13.
PubMed 29654514Westerbacka J, Duverne M, Grulovic N, Thummisetti S, Doder Z. Insulin glargine 300 U/mL safety data in pregnancy. Diabetes Obes Metab. 2025 May;27(5):2322-2325. doi: 10.1111/dom.16295. Epub 2025 Mar 19. No abstract available.
PubMed 40105254American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.
PubMed 30461693
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin
- ClinicalTrials.gov ID
- NCT07224893
- Acronym / sponsor ID
- 25-09-FB-0214
- Conditions
- Pregestational Diabetes, Pregnancy
- Keywords
- continuous glucose monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Nov 2025 (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 purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once-Daily Insulin Glargine | Active comparator | Drug: Use of insulin glargine once dailyParticipants randomized to this arm will take insulin glargine once daily |
| Twice-Daily Insulin Glargine | Experimental | Drug: Use of insulin glargine twice dailyParticipants randomized to this arm will take insulin glargine twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years of age;
- The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
- Type II diabetes mellitus requiring insulin;
- The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.
- Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management
Key exclusion criteria (5 listed)
- Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;
- Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;
- Known or suspected fetal anomaly or aneuploidy;
- Prisoners;
- Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
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 |
|---|---|---|
| Use of insulin glargine once dailyInsulin glargine will be used once daily | Drug | Once-Daily Insulin Glargine |
| Use of insulin glargine twice dailyInsulin glargine will be used twice daily | Drug | Twice-Daily Insulin Glargine |
Primary outcome
Weekly Time in Range
Time frame: From Day 7 to Day 14 after study enrollment
The mean blood glucose time in range as measured by the continuous glucose monitor
31 secondary outcomes
Hypertensive disorders of pregnancy
Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment
Preterm birth <34 weeks
Time frame: From time of enrollment to 34 weeks gestation
Preterm birth <37 weeks
Time frame: From time of enrollment until 37 weeks gestation
Spontaneous or Indicated Delivery
Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment
Operative vaginal delivery
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Cesarean Delivery
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Estimated blood loss
Time frame: Duration of labor, up to 24 hours
Quantitative blood loss
Time frame: Duration of labor, up to 24 hours
Blood transfusion
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Endometritis
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Chorioamnionitis
Time frame: From time of enrollment until time of hospital discharge (up to 42 days post-delivery)
Wound infection
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Venous thromboembolism
Time frame: From time of enrollment to time of hospital discharge (up to 42 days post-delivery)
Massive transfusion and postpartum hemorrhage
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
ICU admission
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Maternal death
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Antepartum death
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Intrapartum death
Time frame: Duration of labor, up to 24 hours
Neonatal Intubation within 72 hours of birth
Time frame: From time of delivery to 72 hours later
Continuous positive airway pressure (CPAP) within 72 hours of birth
Time frame: From time of delivery to 72 hours later
High-flow nasal cannula (HFNC) within 72 hours of birth
Time frame: From time of delivery to 72 hours later
Cardiopulmonary resuscitation within 72 hours of birth
Time frame: From time of delivery to 72 hours later
Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Birthweight
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Neonatal encephalopathy
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Seizures
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Shoulder dystocia
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Birth trauma
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Intracranial hemorrhage
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
NICU admission
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
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 15 May 2026.
- BackgroundGabbe SG, Calfas J, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies. Elsevier; 2017. doi:10.1016/C2013-0-00408-2
- Background: PubMed 35858653Fishel Bartal M, Ashby Cornthwaite JA, Ghafir D, Ward C, Ortiz G, Louis A, Cornthwaite J, Chauhan SSP, Sibai BM. Time in Range and Pregnancy Outcomes in People with Diabetes Using Continuous Glucose Monitoring. Am J Perinatol. 2023 Apr;40(5):461-466. doi: 10.1055/a-1904-9279. Epub 2022 Jul 20.
- Background: PubMed 33540243Jethwani P, Saboo B, Jethwani L, Chawla R, Maheshwari A, Agarwal S, Jaggi S. Use of insulin glargine during pregnancy: A review. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):379-384. doi: 10.1016/j.dsx.2021.01.012. Epub 2021 Jan 22.
- Background: PubMed 26452316Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol. 2015 Nov;39(7):512-9. doi: 10.1053/j.semperi.2015.08.003.
- Background: PubMed 30619716Eledrisi M, Suleiman NN, Salameh O, Khair Hamad M, Rabadi O, Mohamed A, Al Adawi R, Salam A. Twice-daily insulin glargine for patients with uncontrolled type 2 diabetes mellitus. J Clin Transl Endocrinol. 2018 Dec 11;15:35-36. doi: 10.1016/j.jcte.2018.12.002. eCollection 2019 Mar. No abstract available.
- Background: PubMed 16911626Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006 Aug;23(8):879-86. doi: 10.1111/j.1464-5491.2006.01913.x.
- Background: PubMed 11118018Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A, Cordoni C, Costa E, Brunetti P, Bolli GB. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000 Dec;49(12):2142-8. doi: 10.2337/diabetes.49.12.2142.
- Background: PubMed 10834424Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care. 2000 May;23(5):644-9. doi: 10.2337/diacare.23.5.644.
- Background: PubMed 29654514Candido R, Wyne K, Romoli E. A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus. Diabetes Ther. 2018 Jun;9(3):927-949. doi: 10.1007/s13300-018-0422-4. Epub 2018 Apr 13.
- Background: PubMed 40105254Westerbacka J, Duverne M, Grulovic N, Thummisetti S, Doder Z. Insulin glargine 300 U/mL safety data in pregnancy. Diabetes Obes Metab. 2025 May;27(5):2322-2325. doi: 10.1111/dom.16295. Epub 2025 Mar 19. No abstract available.
- Background: PubMed 30461693American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use of insulin glargine once daily and Use of insulin glargine twice daily in people with Pregestational Diabetes and Pregnancy, run by Eastern Virginia Medical School 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 5 inclusion and 5 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 15 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marwan Ma'ayeh, MD (7574467900, maayehmg@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Time in Range (time frame: From Day 7 to Day 14 after study enrollment). 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 NCT07224893, which also lists 11 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 15 May 2026.