Gestational Diabetes Mellitus in PregnancyCGMSGDMLABORNCT05067075
The CGMS in GDM Labor and Delivery Study
A study testing Blinded CGM in people with Gestational Diabetes Mellitus in Pregnancy, run by Woman's at 1 site in United States.
Trial summary
Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Blinded CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- a positive oral glucose tolerance test
- written informed consent
- labor scheduled for term induction (37-40 weeks)
Who cannot join
- prior diagnosis of type 1 or type 2 diabetes mellitus
- presence of infection
- Presence of significant systemic disease or other severe metabolic, endocrine, or medical co-morbidities
- History of bariatric surgery or other surgeries that induce malabsorption
- Long-term use (>2 weeks) of systemic steroids prior to enrollment
- Multiple pregnancy
Show all 10Show fewer
- Participants already using glucose lowering medications (metformin or insulin) for diabetes before study entry (can be used after diagnosis of GDM)
- Fetal growth restriction due to placental dysfunction or known congenital anomaly
- History of major depressive or other severe psychiatric disorders or inpatient psychiatric treatment up to 1 year before enrolment
- Inability or refusal to comply with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Continuous Glucose Monitoring Systems (CGMS) for Intrapartum Metabolic Control in Gestational Diabetic (GDM)Women
Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemia is a risk for the offspring of pregnant women with diabetes and occurs when fetal pancreatic hyperplasia is acutely stimulated by a high fetal glucose level derived from maternal hyperglycemia during labor. The maternal blood glucose level during delivery is a predictor of the neonatal blood glucose level. Modern continuous glucose monitoring (CGM) systems can capture the direction and magnitude of short-lived changes in interstitial glucose levels and are therefore useful for assessing glucose variability more accurately than self-monitoring blood glucose (SMBG) measurements. Indeed, it has already been demonstrated that intermittent blood glucose monitoring underestimates the number of hyperglycemic events, because blood glucose excursions can peak at different times of day. CGMs can help identify glycemic patterns in pregnancy, obtain and maintain glucose targets, and reduce hypoglycemia. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. Two groups have reported on the use of CGM in type 1 diabetics during labor in small pilot studies. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 h before birth) and resultant neonatal hypoglycemia. The researchers found that maternal hyperglycemia before delivery was correlated with neonatal hypoglycemia. Although more studies are needed, CGM use has promise as a therapy to improve outcomes in pregnancies associated with diabetes. In this study, the investigators plan to explore whether the use of blinded glucose monitoring during labor, delivery, and early postpartum supplementary to normally monitored plasma glucose measurements in women with gestational diabetes (GDM) would provide useful information to improve glycemia during labor in this diabetic population. All CGM data will be masked and therefore not available to participants, clinicians, or researchers at the time of delivery. Participants otherwise will receive standard clinical care. The blinded glucose monitoring data on glycemia throughout labor and post-delivery will be retrospectively assessed.
Read the detailed description
Planning management for a diabetic parturient during labor and delivery is particularly challenging because of the demands of labor, dietary restrictions, and potential for operative delivery. The main goals can be summarized as: ensuring the avoidance of maternal hypoglycemia or hyperglycemia (which can increase the risk of neonatal hypoglycemia), ensuring the safe use of measures to manage glycemic control, and the provision of effective analgesia for labor. Currently available international guidelines for the peripartum management of pregnant women with diabetes focus on rigorous intrapartum glycemic control. Maternal hyperglycemia in women with pregestational and gestational diabetes mellitus can cause hypoglycemia in the neonate following delivery. In women with diabetes, maternal hyperglycemia leads to hyperplasia of pancreatic β cells in the fetus and an increase in fetal insulin concentrations. When the continuous supply of glucose is stopped after delivery, the neonate is at risk of developing hypoglycemia, which if untreated can have serious neurological consequences. The increase in fetal insulin also contributes to the excess growth of the fetus in mothers with hyperglycemia. Avoiding intrapartum maternal hyperglycemia may prevent fetal hyperglycemia and reduce the likelihood of subsequent neonatal hypoglycemia. A further potential concern relates directly to the woman. Immediately after delivery, postpartum insulin requirements decrease dramatically as a result of the rapid decrease in diabetogenic placental hormone levels and resulting dissipation of pregnancy-induced insulin resistance. Pregnant women with diabetes may be at greater risk of hypoglycemic episodes because awareness of the symptoms of hypoglycemia is reduced, and this is further exacerbated by tight glycemic control .
Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemia is a risk for the offspring of pregnant women with diabetes and occurs when fetal pancreatic hyperplasia is acutely stimulated by a high fetal glucose level derived from maternal hyperglycemia during labor. The maternal blood glucose level during delivery is a predictor of the neonatal blood glucose level, and a high blood glucose level in the mother is associated with neonatal hypoglycemia. Continuous glucose monitoring (CGM) use appears to be safe and effective in pregnancies complicated by diabetes. Modern CGM systems can capture the direction and magnitude of short-lived changes in interstitial glucose levels and are therefore useful for assessing glucose variability more accurately than self-monitoring blood glucose (SMBG) measurements. Indeed, it has already been demonstrated that intermittent blood glucose monitoring underestimates the number of hyperglycemic events because blood glucose excursions can peak at different times of day. CGMs can help identify glycemic patterns in pregnancy, obtain and maintain glucose targets, and reduce hypoglycemia. CGM helps with treatment adjustments in pregnancies associated with diabetes. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. In principle, "real-time" CGM might allow more rapid adjustment of insulin dosing and, thereby, yield better glycemic control than is possible with intermittent glucose monitoring. Two groups have reported on the use of CGM during labor in small pilot studies. Stenninger et al. reported that CGM was well tolerated in their 15 subjects and that elevated maternal glucose levels in the last 2 hours before delivery correlated with the need for intravenous glucose in the newborn. They found that multiple glycemic indices correlated positively with the need for neonatal intravenous glucose infusions. Iafusco et al. used real-time CGM in 14 subjects to guide insulin therapy during labor and found no cases of neonatal hypoglycemia. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 hours before birth) and resultant neonatal hypoglycemia. In the this study, 45% (27/60) of women in the CGM group were compared with 100% (59/59) in the control group. Among women in the CGM arm, 10 infants developed hypoglycemia compared with 27 in the non-CGM group (37% vs. 46%, respectively; P = 0.45). The researchers found that maternal hyperglycemia before delivery was correlated with neonatal hypoglycemia.
Although more studies are needed, CGM use has promise as a therapy to improve outcomes in pregnancies associated with diabetes. In this study, the investigators plan to explore whether the use of blinded glucose monitoring during labor, delivery, and early postpartum supplementary to normally monitored plasma glucose measurements in women with gestational diabetes (GDM) would provide useful information to improve glycemia during labor in this diabetic population.
- Being tested
- Blinded CGM
- Keywords
- continuous glucose monitoring, labor, post-delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded CGMDevice
Also called Dexcom G6 Pro
CGM that records blood glucose but is not visible to patient or provider in real-time
| Study group | Role | What they receive |
|---|---|---|
| Blinded CGM | Experimental | Blinded continuous glucose monitor Dexcom G6Pro Receives: Device: Blinded CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average percentage time in target glucose range
average time in hours and minutes spent in target glucose range
Measured: up to 10 days
Secondary outcomes (3)
average time spent in hyperglycemia (time above target range)
average time in hours and minutes spent with elevated blood sugar
Measured: up to 10 days
average time spent in hypoglycemia (time below target range)
average time in hours and minutes spent with low blood sugar
Measured: up to 10 days
neonatal hypoglycemia
Neonatal hypoglycemia is defined as a 2-hour plasma glucose value < 2.1 mmol/l (47 mg/dL taken 2 hours after delivery
Measured: up to 2 hours post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Nov 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
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 Gestational Diabetes Mellitus in PregnancyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blinded continuous glucose monitor will be compared with routine blood glucose monitoring
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Karen Elkind-Hirsch, PhD, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067075
- Sponsor's protocol ID
- RP-21-017
- Acronym
- CGMSGDMLABOR
- Status last verified
- Aug 2023
- First submitted
- 22 Sep 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The proposed research will involve a small sample (less than 65 subjects) recruited from clinical facilities at Woman's Hospital. Despite the removal of all identifiers, we believe that it would be difficult if not impossible to protect the identities of subjects. So even though the final dataset will be stripped of identifiers prior to release for sharing, we assume that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the de- identified data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
Publications
Elkind-Hirsch KE, Armatta M, Veillon E, Schiavon S, Cappon G. Relationship between continuous maternal intrapartum and postpartum glucose monitoring metrics and neonatal outcomes and postpartum glucose metabolism in individuals with gestational diabetes. BMC Pregnancy Childbirth. 2026 Mar 16;26(1):450. doi: 10.1186/s12884-026-08944-2.
PubMed 41840522
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Continuous Glucose Monitoring Systems (CGMS) for Intrapartum Metabolic Control in Gestational Diabetic (GDM)Women
- ClinicalTrials.gov ID
- NCT05067075
- Acronym / sponsor ID
- CGMSGDMLABOR / RP-21-017
- Keywords
- continuous glucose monitoring, labor, post-delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 5 Oct 2021 (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.
Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemia is a risk for the offspring of pregnant women with diabetes and occurs when fetal pancreatic hyperplasia is acutely stimulated by a high fetal glucose level derived from maternal hyperglycemia during labor. The maternal blood glucose level during delivery is a predictor of the neonatal blood glucose level. Modern continuous glucose monitoring (CGM) systems can capture the direction and magnitude of short-lived changes in interstitial glucose levels and are therefore useful for assessing glucose variability more accurately than self-monitoring blood glucose (SMBG) measurements. Indeed, it has already been demonstrated that intermittent blood glucose monitoring underestimates the number of hyperglycemic events, because blood glucose excursions can peak at different times of day. CGMs can help identify glycemic patterns in pregnancy, obtain and maintain glucose targets, and reduce hypoglycemia. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. Two groups have reported on the use of CGM in type 1 diabetics during labor in small pilot studies. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 h before birth) and resultant neonatal hypoglycemia. The researchers found that maternal hyperglycemia before delivery was correlated with neonatal hypoglycemia. Although more studies are needed, CGM use has promise as a therapy to improve outcomes in pregnancies associated with diabetes. In this study, the investigators plan to explore whether the use of blinded glucose monitoring during labor, delivery, and early postpartum supplementary to normally monitored plasma glucose measurements in women with gestational diabetes (GDM) would provide useful information to improve glycemia during labor in this diabetic population. All CGM data will be masked and therefore not available to participants, clinicians, or researchers at the time of delivery. Participants otherwise will receive standard clinical care. The blinded glucose monitoring data on glycemia throughout labor and post-delivery will be retrospectively assessed.
Detailed description
Planning management for a diabetic parturient during labor and delivery is particularly challenging because of the demands of labor, dietary restrictions, and potential for operative delivery. The main goals can be summarized as: ensuring the avoidance of maternal hypoglycemia or hyperglycemia (which can increase the risk of neonatal hypoglycemia), ensuring the safe use of measures to manage glycemic control, and the provision of effective analgesia for labor. Currently available international guidelines for the peripartum management of pregnant women with diabetes focus on rigorous intrapartum glycemic control. Maternal hyperglycemia in women with pregestational and gestational diabetes mellitus can cause hypoglycemia in the neonate following delivery. In women with diabetes, maternal hyperglycemia leads to hyperplasia of pancreatic β cells in the fetus and an increase in fetal insulin concentrations. When the continuous supply of glucose is stopped after delivery, the neonate is at risk of developing hypoglycemia, which if untreated can have serious neurological consequences. The increase in fetal insulin also contributes to the excess growth of the fetus in mothers with hyperglycemia. Avoiding intrapartum maternal hyperglycemia may prevent fetal hyperglycemia and reduce the likelihood of subsequent neonatal hypoglycemia. A further potential concern relates directly to the woman. Immediately after delivery, postpartum insulin requirements decrease dramatically as a result of the rapid decrease in diabetogenic placental hormone levels and resulting dissipation of pregnancy-induced insulin resistance. Pregnant women with diabetes may be at greater risk of hypoglycemic episodes because awareness of the symptoms of hypoglycemia is reduced, and this is further exacerbated by tight glycemic control .
Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemia is a risk for the offspring of pregnant women with diabetes and occurs when fetal pancreatic hyperplasia is acutely stimulated by a high fetal glucose level derived from maternal hyperglycemia during labor. The maternal blood glucose level during delivery is a predictor of the neonatal blood glucose level, and a high blood glucose level in the mother is associated with neonatal hypoglycemia. Continuous glucose monitoring (CGM) use appears to be safe and effective in pregnancies complicated by diabetes. Modern CGM systems can capture the direction and magnitude of short-lived changes in interstitial glucose levels and are therefore useful for assessing glucose variability more accurately than self-monitoring blood glucose (SMBG) measurements. Indeed, it has already been demonstrated that intermittent blood glucose monitoring underestimates the number of hyperglycemic events because blood glucose excursions can peak at different times of day. CGMs can help identify glycemic patterns in pregnancy, obtain and maintain glucose targets, and reduce hypoglycemia. CGM helps with treatment adjustments in pregnancies associated with diabetes. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. In principle, "real-time" CGM might allow more rapid adjustment of insulin dosing and, thereby, yield better glycemic control than is possible with intermittent glucose monitoring. Two groups have reported on the use of CGM during labor in small pilot studies. Stenninger et al. reported that CGM was well tolerated in their 15 subjects and that elevated maternal glucose levels in the last 2 hours before delivery correlated with the need for intravenous glucose in the newborn. They found that multiple glycemic indices correlated positively with the need for neonatal intravenous glucose infusions. Iafusco et al. used real-time CGM in 14 subjects to guide insulin therapy during labor and found no cases of neonatal hypoglycemia. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 hours before birth) and resultant neonatal hypoglycemia. In the this study, 45% (27/60) of women in the CGM group were compared with 100% (59/59) in the control group. Among women in the CGM arm, 10 infants developed hypoglycemia compared with 27 in the non-CGM group (37% vs. 46%, respectively; P = 0.45). The researchers found that maternal hyperglycemia before delivery was correlated with neonatal hypoglycemia.
Although more studies are needed, CGM use has promise as a therapy to improve outcomes in pregnancies associated with diabetes. In this study, the investigators plan to explore whether the use of blinded glucose monitoring during labor, delivery, and early postpartum supplementary to normally monitored plasma glucose measurements in women with gestational diabetes (GDM) would provide useful information to improve glycemia during labor in this diabetic population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blinded continuous glucose monitor will be compared with routine blood glucose monitoring
| Arm | Type | Receives |
|---|---|---|
| Blinded CGM | Experimental | Device: Blinded CGMBlinded continuous glucose monitor Dexcom G6Pro |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancy
- a positive oral glucose tolerance test
- written informed consent
- labor scheduled for term induction (37-40 weeks)
Key exclusion criteria (10 listed)
- prior diagnosis of type 1 or type 2 diabetes mellitus
- presence of infection
- Presence of significant systemic disease or other severe metabolic, endocrine, or medical co-morbidities
- History of bariatric surgery or other surgeries that induce malabsorption
- Long-term use (>2 weeks) of systemic steroids prior to enrollment
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 |
|---|---|---|
| Blinded CGMAlso: Dexcom G6 ProCGM that records blood glucose but is not visible to patient or provider in real-time | Device | Blinded CGM |
Primary outcome
Average percentage time in target glucose range
Time frame: up to 10 days
average time in hours and minutes spent in target glucose range
3 secondary outcomes
average time spent in hyperglycemia (time above target range)
Time frame: up to 10 days
average time spent in hypoglycemia (time below target range)
Time frame: up to 10 days
neonatal hypoglycemia
Time frame: up to 2 hours post delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Derived from this study: PubMed 41840522Elkind-Hirsch KE, Armatta M, Veillon E, Schiavon S, Cappon G. Relationship between continuous maternal intrapartum and postpartum glucose monitoring metrics and neonatal outcomes and postpartum glucose metabolism in individuals with gestational diabetes. BMC Pregnancy Childbirth. 2026 Mar 16;26(1):450. doi: 10.1186/s12884-026-08944-2.
- Individual participant dataSharing planned: No. The proposed research will involve a small sample (less than 65 subjects) recruited from clinical facilities at Woman's Hospital. Despite the removal of all identifiers, we believe that it would be difficult if not impossible to protect the identities of subjects. So even though the final dataset will be stripped of identifiers prior to release for sharing, we assume that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the de- identified data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
Related trials for Gestational Diabetes Mellitus in Pregnancy
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Effects Of Core Canister Training in Pregnant Women With History of Gestational Diabetes Mellitus
Antenatal Care Model, Gestatiaonl Diabetes Mellitus
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
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.
Karen Elkind-Hirsch, PhD principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded CGM in people with Gestational Diabetes Mellitus in Pregnancy, run by Woman's 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 4 inclusion and 10 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 28 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average percentage time in target glucose range (time frame: up to 10 days). 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 NCT05067075, 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 28 Aug 2023.