Insulin Therapy for Gestational Diabetes
(GAP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Pre-gestational diabetes, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications. However, if you have already started medication for gestational diabetes before joining the study, you cannot participate.
What data supports the effectiveness of insulin therapy for gestational diabetes?
Research shows that insulin analogs like Humalog and insulin detemir are effective in managing blood sugar levels during pregnancy, which is crucial for reducing complications in diabetic women. Studies indicate that these insulins help achieve good metabolic control without adverse effects on mothers or babies.
12345Is insulin therapy safe for use during pregnancy and in people with diabetes?
Research shows that insulin analogs like lispro, aspart, glargine, and detemir are safe for use during pregnancy and do not cross the placenta, meaning they don't harm the baby. These insulins have been found to reduce blood sugar fluctuations, which is important for both mother and baby.
678910How does insulin therapy differ from other treatments for gestational diabetes?
Insulin therapy for gestational diabetes is unique because it involves direct administration of insulin to manage blood sugar levels, which can be more effective for some women compared to oral medications like metformin. Insulin can be tailored in terms of dosage and timing to achieve precise blood sugar control, especially in cases where other treatments are insufficient.
1112131415Eligibility Criteria
This trial is for pregnant women over 18 with gestational diabetes who can communicate in English and check their blood sugar at least twice a day. It's not for those with pre-gestational diabetes, fasting blood sugar >=126 mg/dL, post-meal levels >=200 mg/dL, or already on pharmacotherapy.Inclusion Criteria
I am 18 years old or older.
You have been diagnosed with gestational diabetes.
Able to communicate in English
+1 more
Exclusion Criteria
You have already started taking medication before being referred to the study.
You have diabetes before getting pregnant.
You do not regularly check your blood sugar levels at least two times a day, even after getting proper advice.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Pregnant women with GDM are randomized to start pharmacotherapy at either 20% or 40% of elevated CBG values
Duration of pregnancy until delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neonatal outcomes
6 weeks postpartum
Participant Groups
The GAP study is testing when to start insulin treatment for gestational diabetes by comparing two groups: one starts treatment if at least 20% of their blood glucose readings are high, the other waits until at least 40% are high.
2Treatment groups
Active Control
Group I: 20% cutoff groupActive Control1 Intervention
Treatment intervention will be initiated with insulin if 20% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.
Group II: 40% cutoff groupActive Control1 Intervention
Treatment intervention will be initiated with insulin if 40% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.
Insulin is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Insulin for:
- Diabetes mellitus
🇺🇸 Approved in United States as Insulin for:
- Diabetes mellitus
🇨🇦 Approved in Canada as Insulin for:
- Diabetes mellitus
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical College of WisconsinMilwaukee, WI
Loading ...
Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy. [2022]Pregnancy outcome in diabetic women is strictly related to glycemic control during pregnancy. The aim of our study was to compare pregnancy outcome between patients subjected to intensive insulin therapy using regular human insulin and those treated with insulin lispro (Humalog).
Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. [2016]We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy.
Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open‑label, multinational, randomised, controlled, non-inferiority trial. [2023]Insulin degludec (degludec) is a second-generation basal insulin with an improved pharmacokinetic-pharmacodynamic profile compared with first-generation basal insulins, but there are few data regarding its use during pregnancy. In this non-inferiority trial, we aimed to compare the efficacy and safety of degludec with insulin detemir (detemir), both in combination with insulin aspart (aspart), in pregnant women with type 1 diabetes.
Insulin analogs and pregnancy: an update. [2015]It is well known that good metabolic control maintained throughout pregnancy reduces maternal and fetal complications in diabetes. Before conception and throughout pregnancy, insulin therapy needs to be optimized and, in this context, the insulin analogs currently available in the market may help to achieve good metabolic control. We therefore review here what is known about the potential benefits and risks related to the use of these new insulins in pregnancy. Clinical and experimental data on insulin aspart and lispro strongly suggest that they have no adverse maternal or fetal effects during pregnancy in women with pregestational and gestational diabetes, and that their use results in improved glycemic control, fewer hypoglycemic episodes, and improved patient satisfaction. At present there are no published data on the use of glulisine in pregnancy. Insulin glargine during pregnancy is not recommended but, in the last years, larger surveys (retrospective and case-control studies) have been published on this field and, to date, results of about 335 pregnancies with type 1 diabetes are available showing an incidence of congenital malformation similar to that obtained with human insulin. There are no published data concerning the use of detemir in pregnancy but the results of a prospective study are expected in 2010.
Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. [2022]As basal insulin analogues are being used off-label, there is a need to evaluate their safety (maternal hypoglycaemia and fetal and perinatal outcomes) and efficacy [haemoglobin A1c(HbA1c), fasting plasma glucose, and maternal weight gain]. The aim of this review is to provide an overview of the current literature concerning basal insulin analogue use in diabetic pregnancy, and to present the design and preliminary, non-validated baseline characteristics of a currently ongoing randomized, controlled, open-label, multicentre, multinational trial comparing insulin detemir with neutral protamine hagedorn insulin, both with insulin aspart, in women with type 1 diabetes planning a pregnancy (n = 306) or are already pregnant (n = 164). Inclusion criteria include type 1 diabetes > 12 months' duration; screening HbA1c ≤ 9.0% (women recruited prepregnancy), or pregnant with gestational age 8-12 weeks and HbA1c ≤ 8.0% at randomization. At confirmation of pregnancy all subjects must have HbA1c ≤ 8.0%. Exclusion criteria include impaired hepatic function, cardiac problems, and uncontrolled hypertension. Subjects are randomized to either insulin detemir or neutral protamine hagedorn insulin, both with prandial insulin aspart. The results are expected mid-2011 with full publications expected later this year. Baseline characteristics show that basal insulin analogues are already frequently used in pregnant women with type 1 diabetes. This study will hopefully elucidate the safety and efficacy of the basal insulin analogue detemir in diabetic pregnancy.
Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. [2020]To evaluate the safety profile of insulin detemir (IDet) in people with Type 2 diabetes mellitus (T2DM) in the Gulf countries in the 32-week, noninterventional LevSafe study.
Treatment with the long-acting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. [2015]To compare glycaemic control and pregnancy outcome in women with type 1 diabetes treated with the long-acting insulin analogues detemir or glargine.
Safety of insulin analogs during pregnancy: a meta-analysis. [2022]The objective of this study was to assess the safety of four insulin analogs (aspart, lispro, glargine, and detemir) for the treatment of diabetes in pregnancy.
The care of pregestational and gestational diabetes and drug metabolism considerations. [2017]Normal pregnancy development involves gradual decline in insulin sensitivity, which sometimes requires pharmacotherapy. Insulin is the drug of choice for gestational and pregestational diabetes. Metabolism of traditional insulins results in inadequate onset and duration of action and marked peak activity. These properties increase risk of excessive glucose excursions, which are especially undesirable during pregnancy. Insulin analogs have been emerging as a safer and more effective treatment of diabetes during pregnancy. Areas covered: This manuscript reviews currently used antihyperglycemic agents: fast and long-acting insulins, metformin and glyburide. Trials demonstrating their efficacy and safety during pregnancy are described. Certain drug metabolism considerations (e.g. affinity to IGF-1) are emphasized. Expert opinion: The theories that insulin analogs bind to immunoglobulin and cross placenta have been disproved. Lispro, aspart, glargine and detemir do not transfer across the placenta and do not result in adverse maternal and neonatal outcomes. In addition, favorable pharmacokinetic profiles (rapid onset and 24-hour near peakless activity) substantially reduce blood glucose variability including hypoglycemia. We believe that insulin analogs should be given strong consideration for the treatment of diabetes during pregnancy. Metformin has also proven to be safe and may be considered as an initial single agent for milder gestational diabetes.
Efficacy and Safety of Basal Analog Regimens in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]This study compared basal analog (BA: glargine U100/mL and detemir) and premix (PM: human, lispro and aspart biphasic) insulin regimens in terms of their efficacy and safety in type 2 diabetes mellitus patients.
Use of insulin pumps in pregnancies complicated by type 2 diabetes and gestational diabetes in a multiethnic community. [2021]To describe the use of insulin pump therapy in women with gestational diabetes mellitus (GDM) or type 2 diabetes in pregnancy and persistent hyperglycemia despite multiple injections of subcutaneous insulin.
Correlates of Insulin Selection as a First-Line Pharmacological Treatment for Gestational Diabetes. [2023]The aim of this study was to investigate prenatal factors associated with insulin prescription as a first-line pharmacotherapy for gestational diabetes mellitus (GDM; compared with oral antidiabetic medication) after failed medical nutrition therapy.
[Outcome of non-pharmacologic treatment in a gestational diabetic woman with high insulin resistance HOMA-IR index and allergy to human insulin. Case report]. [2017]Gestational diabetes is a syndrome of significant pathophysiological and clinical heterogeneity. This type of diabetes mellitus can be treated with diet, exercise and insulin in cases of unsatisfactory results of nonpharmacologic treatment. It has been reported the case of a 28-year -old female with gestational diabetes treated with high doses of insulin (128 U/per day) on four injections regimens. During the therapy allergic type III reactions to human insulin preparations (Ultratard HM, Actrapid HM Humulin U, Humulin R, Humalog) has been occurred at the injection site. The insulin was omitted. We applied diet modification and 15-30 minutes walking before meals till the afternoon with god metabolic control. High insulin resistance index HOMA-IR, type 2 diabetes history in both parents god metabolic control of nonpharmacologic treatment, and impaired glucose tolerance after post-partum may suggest, the early stage of diabetes type 2 in presented case.
Fasting blood glucose predicts response to extended-release metformin in gestational diabetes mellitus. [2014]Metformin is increasingly accepted as an alternative to insulin therapy in gestational diabetes mellitus (GDM). The Metformin in Gestational Diabetes (MiG) trial reported similar pregnancy outcomes for metformin versus insulin; however, supplemental insulin was required in 46% of women on metformin.
[Insulin Lispro as an alternative for insulin Humulin U in the treatment of an obese gestational diabetic woman with allergy to Humulin U. Case report]. [2011]It has been reported the case of 32-year-old obese gestational diabetic woman, treated with Humulin U and Humalog from 28 week of gestation. Seventeen days after initiation of insulin Humulin U the woman developed allergic type I cutaneous changes. During the few minutes following injection of Humulin U, the local wheal-flare reactions accompanied by itching has been occurred. These symptoms have been disappeared after a few hours. Insulin Humulin U was discontinued (18 j). Glycemia were monitored every 1-2 hours between 8 pm-6 am. Glycemia were in normal range between 8 pm. till 5 am. We have observed increase of glycemia to 6.34 mmol/l between 5 am.-6 am. The therapy was converted to Humalog injected at 5 30 am with glycemic control one hour later. The glycemic control was very good till next dose of Humalog before breakfast. The doses of Humalog were systematically increased at 5.30 am depend on glycemia at 6.30 with highest doses in 37 week of pregnancy (30 j with 180 j a day). The good glycemic control was maintained till delivery (38 week of pregnancy). That method of therapy was good tolerated and was not strenuous in spite of necessity of early awakening. We suggest that in obese gestational diabetics ultra-short insulin preparation, analog of short acting human insulin (Humalog), injected at 5.30 am might be considered as a therapeutic alteration for long acting insulin injected at evening. This observation may be interesting especially in situations in which long acting insulin injected at evening must be discontinued.