Insulin Management Strategies for Diabetes during Pregnancy
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Alabama at Birmingham
Must be taking: Insulin, Metformin
Disqualifiers: Major fetal anomaly, Triplet, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with diabetes and threatened PTB.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it involves testing different insulin strategies, so you may need to adjust your insulin treatment.
What data supports the effectiveness of insulin therapy for managing diabetes during pregnancy?
Research shows that flexible, intensive insulin management improves blood sugar control and treatment satisfaction in type 1 diabetes, which suggests that similar strategies could be beneficial for managing diabetes during pregnancy.
12345Is insulin management during pregnancy safe for women with diabetes?
Research shows that while antenatal corticosteroids like betamethasone can help reduce complications in newborns, they may cause high blood sugar levels in pregnant women with diabetes. This suggests that careful monitoring and management of insulin are important to ensure safety during pregnancy.
678910How does the drug antenatal corticosteroids differ from other treatments for diabetes during pregnancy?
Antenatal corticosteroids like betamethasone are unique because they are used to reduce complications in preterm births, but they can cause high blood sugar levels, requiring careful insulin management in pregnant women with diabetes.
610111213Eligibility Criteria
This trial is for pregnant women aged 18-50 with gestational or pregestational type 2 diabetes, treated with insulin injections or medications like metformin. They must be hospitalized for corticosteroid administration due to the risk of premature birth between weeks 23 and almost 37 of pregnancy.Inclusion Criteria
I am a woman aged between 18 and 50.
You are between 23 weeks and 36 weeks pregnant.
Hospitalized for antenatal corticosteroid administration in anticipation of preterm birth
+1 more
Exclusion Criteria
You are planning to give birth within 72 hours after receiving the first dose of antenatal corticosteroids.
Triplet or higher order multiple gestation
The participant has a major abnormality in the unborn baby.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one of three insulin treatment strategies for glycemic control after antenatal corticosteroids
5 days
Daily monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of the Diabetes Treatment Satisfaction Questionnaire
1 week
Delivery and Neonatal Monitoring
Umbilical cord blood is collected at delivery, and neonates are monitored for glucose levels and respiratory morbidity
Birth to hospital discharge, assessed up to 28 days
Participant Groups
The study tests three strategies to control blood sugar after receiving corticosteroids: adding sliding scale insulin, increasing usual home insulin doses, and giving continuous insulin infusions. It also uses a Dexcom G6 monitor to track glucose levels.
3Treatment groups
Experimental Treatment
Group I: Up-Titration of Home InsulinExperimental Treatment2 Interventions
Increase in home insulin regimen based on standardized algorithm for maximum of 5 days after antenatal corticosteroids
Group II: Sliding Scale InsulinExperimental Treatment2 Interventions
Addition of supplemental sliding scale insulin to home insulin regimen for maximum of 5 days after antenatal corticosteroids
Group III: Continuous Insulin InfusionExperimental Treatment2 Interventions
Discontinuation of home insulin regimen and receipt of continuous insulin infusion for maximum of 5 days after antenatal corticosteroids
Antenatal Corticosteroids is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Betamethasone for:
- Antenatal corticosteroid therapy for fetal maturation
- Inflammatory conditions
- Allergic states
- Dermatologic disorders
- Gastrointestinal diseases
- Hematological disorders
🇺🇸 Approved in United States as Betamethasone for:
- Antenatal corticosteroid therapy for fetal maturation
- Inflammatory conditions
- Allergic states
- Dermatologic disorders
- Gastrointestinal diseases
- Hematological disorders
🇨🇦 Approved in Canada as Betamethasone for:
- Antenatal corticosteroid therapy for fetal maturation
- Inflammatory conditions
- Allergic states
- Dermatologic disorders
- Gastrointestinal diseases
- Hematological disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Health Science Center at HoustonHouston, TX
Oregon Health and Science UniversityPortland, OR
University of Alabama at BirminghamBirmingham, AL
University of South Carolina Greenville / Prisma Health-UpstateGreenville, SC
Loading ...
Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Insulin therapy in type 2 diabetes mellitus: a practical approach for primary care physicians and other health care professionals. [2022]The responsibility of diabetes management and insulin therapy has definitively moved to primary care physicians. Within the primary care setting, there is a growing need for clear, evidence-based guidelines related to the management of insulin therapy. Straightforward algorithms regarding insulin initiation, titration, and follow-up management can help physicians effectively treat patients with type 2 diabetes mellitus. Once 2 oral diabetic drugs have failed in a patient whose disease duration is 7 to 10 years, use of insulin therapy with a basal insulin analog should be considered. For patients who receive maximal basal insulin doses without reaching fasting blood glucose and target glycated hemoglobin levels with basal insulin analogs, a mealtime-insulin intensification approach should be considered. The authors discuss how simplified insulin initiation and titration regimens allow primary care physicians and other health care professionals to care for patients with type 2 diabetes mellitus.
A fairy tale of modern insulin therapy in type 1 diabetes. [2021]In type 1 diabetes, flexible, intensive insulin management improves not only glycemic control but also dietary freedom and treatment satisfaction. Such flexibility has been made possible with the new insulin analogues (as part of a basal-bolus regime) and is now gaining wide applicability, especially among children and adolescents. This approach requires appropriate individualized patient education. Especially for adolescents, the clinician should be able to guarantee insightful participation in direct response to their attitudes, wishes and needs. This patient-and-doctor collaboration is an ever-challenging duty and has the potential to change the future of the individual diabetic patient.
Adherence to Insulin Therapy. [2022]IN BRIEF Six million people with diabetes use insulin either alone or in combination with an oral medication. Many barriers exist that lead to poor adherence with insulin. However, there is an underwhelming amount of data on interventions to address these barriers and improve insulin adherence. Until pharmacological advancements create easier, more acceptable insulin regimens, it is imperative to involve patients in shared decision-making.
Analysis of Glycemic Control of a Pharmacist-Led Medication Management Program in Patients with Type 2 Diabetes. [2023]An integrated health care system with its own regional health plan located in Texas implemented a pharmacist-led diabetes medication management program (MMP) to treat type 2 diabetic patients (baseline A1c > 7.5%). The MMP formed collaborative practice agreements with the system's physicians to allow ambulatory care pharmacists to modify and adjust diabetic drug regimens when appropriate. Enrolled MMP patients received personalized visits with ambulatory care pharmacists and a copay waiver on diabetes medications.
Economic implications of type 2 diabetes management. [2013]Diabetes mellitus (DM) is a complex and progressive disease associated with significant morbidity and mortality. Both the prevalence and economic burden associated with DM have been steadily increasing and are projected to continue to increase. A series of cost reports published by the American Diabetes Association (ADA) between 1997 and 2012 have suggested that direct medical costs are the primary cost driver in DM. Direct costs have increased over 5-fold during this time frame, from $44 billion to $176 billion annually, likely due to both the increased prevalence of DM and increased costs of providing DM-related care. Trends in anti-diabetic medication usage as reported by Centers for Disease Control data from 1997 to 2011 have found that the proportion of diagnosed patients treated for DM has remained fairly stable. However, there has been an increase in the use of oral agents alone, a decrease in patients on insulin only, and a relatively small increase in the percentage of patients using both insulin and oral agents, suggesting stagnation regarding the uptake of insulin use. In parallel, the ADA cost and utilization data suggest that use of medications to treat DM-related comorbidities and complications has risen, which contributes to the risk of medication errors, avoidable adverse drug events, and noncompliance. These data highlight a few of the challenges involved in managing a population of patients with DM. A comprehensive assessment of unmet needs for the population with DM is essential for effective population management. An approach that strives to identify and reduce barriers to patients receiving optimal care and being active participants in their DM management will facilitate systemwide efforts to improve DM outcomes.
Observations on Glucose Excursions With the Use of a Simple Protocol for Insulin, Following Antenatal Betamethasone Administration. [2021]Pregnant women with diabetes often require preterm delivery. Antenatal betamethasone reduces perinatal morbidity and mortality, but induces hyperglycemia. The primary objective was to observe glucose excursions and determine the preliminary safety of a protocol for subcutaneous insulin following betamethasone administration in an antenatal ward.
Pregnant women with diabetes and their clinician's experience of participating in a pilot randomised controlled trial of corticosteroid administration in late pregnancy: A qualitative study. [2023]Little research exists to support the administration of corticosteroids to pregnant women with diabetes. Pregnant women are often excluded from clinical trials due to concerns of harm to the foetus.
Occipitofrontal circumference in newborns of betamethasone treated mothers. [2019]Celestona (betamethasone-disodiumphosphate) and Celeston (betamethasone-acetat + betamethasone-disodiumphosphate) given intramuscularly to pregnant women in order to reduce the frequency of respiratory distress syndrome does not reduce the occipitofrontal circumference of the newborn infants. Before the results from the actual work were available an impeding effect of the evolution of the brain was found in the light of animal experiments. The material is comprised of 52 newborn infants whose mothers were treated with Celestona 8 mg daily for 3 days and 46 infants treated with Celeston 12 mg daily for 3 days. The untreated population comprises 1012 newborn infants. Excluded were non-caucasian infants, twins, stillborns and cases of uncertain gestational age. The occipitofrontal circumference in normal infants and those infants treated with betamethasone were compared in Figs. 2 and 3. Focusing only upon cases in which corticoids were given more than 7 days before delivery and in which no placental dysfunction was diagnosed, no differences from the normal were found (Tabs. II and III, and Figs. 3 A and B).
Antenatal corticosteroids: a reappraisal of the drug formulation and dose. [2021]We review the history of antenatal corticosteroid therapy (ACS) and present recent experimental data to demonstrate that this, one of the pillars of perinatal care, has been inadequately evaluated to minimize fetal exposure to these powerful medications. There have been concerns since 1972 that fetal exposures to ACS convey risk. However, this developmental modulator, with its multiple widespread biologic effects, has not been evaluated for drug choice, dose, or duration of treatment, despite over 30 randomized trials. The treatment used in the United States is two intramuscular doses of a mixture of 6 mg betamethasone phosphate (Beta P) and 6 mg betamethasone acetate (Beta Ac). To optimize outcomes with ACS, the goal should be to minimize fetal drug exposure. We have determined that the minimum exposure needed for fetal lung maturation in sheep, monkeys, and humans (based on published cord blood corticosteroid concentrations) is about 1 ng/ml for a 48-h continuous exposure, far lower than the concentration reached by the current dosing. Because the slowly released Beta Ac results in prolonged fetal exposure, a drug containing Beta Ac is not ideal for ACS use. IMPACT: Using sheep and monkey models, we have defined the minimum corticosteroid exposure for a fetal lung maturation. These results should generate new clinical trials of antenatal corticosteroids (ACS) at much lower fetal exposures to ACS, possibly given orally, with fewer risks for the fetus.
[Antenatal betamethasone during pregnancy with severe diabetes: is better worse than good?]. [2013]Diabetic pregnancy is a precarious situation, both for mother and fetus, because it increases the risk of prematurity and respiratory distress. We report 3 cases of severe acute complications following antenatal betamethasone treatment in mothers presenting with severe diabetes. Corticosteroids are strongly recommended to prevent prematurity complications in newborns. We highlight the high risk profile of theses pregnancies, the effect of this treatment on the mother and the child, and question the real benefit of corticotherapy for these fragile newborns. The metabolic and blood pressure balance is dangerously disturbed in such pregnancies by this treatment. This brings the question of how justified are corticosteroids in such cases?
Glycemic management after antenatal corticosteroid therapy. [2021]Antenatal corticosteroids (ACS) are recommended for use in antenatal mothers at risk of preterm delivery before 34 weeks. One common side-effect of these drugs is their propensity to cause hyperglycemia. A PubMed search was made using terms 'steroid,' 'dexamethasone,' 'betamethasone' with diabetes/glucose. Relevant articles were extracted. In addition, important cross-reference articles were reviewed. This review, based upon this literature search, discusses the available evidence on effects on glycemic status as well as management strategies in women with pre-existing diabetes, gestational diabetes mellitus, as well as normoglycemic women after ACS use in pregnancy.
Maternal and neonatal glycaemic control after antenatal corticosteroid administration in women with diabetes in pregnancy: A retrospective cohort study. [2021]To describe maternal and neonatal glycaemic control following antenatal corticosteroid administration to women with diabetes in pregnancy.
Factors associated with maternal hyperglycaemia and neonatal hypoglycaemia after antenatal betamethasone administration in women with diabetes in pregnancy. [2023]Bespoke glycaemic control strategies following antenatal corticosteroids for women with diabetes in pregnancy (DIP) may mitigate hyperglycaemia. This study aims to identify predictive factors for the glycaemic response to betamethasone in a large cohort of women with DIP.