416 Participants Needed

Insulin Therapy for Gestational Diabetes

(GAP Trial)

AK
ES
AP
ZP
Overseen ByZaira Peterson, RN, MSN
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.

Is 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.12345

How 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.678910

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.1112131415

Eligibility 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

You have been diagnosed with gestational diabetes.
Able to communicate in English
You are pregnant with only one baby.

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.
See 1 more

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

Treatment Details

Interventions

  • Insulin
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

In a study comparing 25 women treated with insulin lispro (Humalog) and 46 treated with regular human insulin, pregnancy outcomes were similar, indicating that both treatments are effective for managing diabetes during pregnancy.
There were no significant differences in key outcomes such as HbA1c levels, pregnancy duration, neonatal birth weight, or rates of complications like preterm labor and cesarean sections, suggesting that Humalog is a safe alternative to regular insulin for pregnant women with diabetes.
Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy.Cypryk, K., Sobczak, M., Pertyńska-Marczewska, M., et al.[2022]
Insulin detemir (IDet) is shown to be noninferior to insulin neutral protamine Hagedorn (NPH) for managing gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnant women, based on a study involving 87 participants.
The study found no significant differences in blood glucose control, maternal weight gain, or perinatal outcomes between the two insulin types, but the NPH group experienced more hypoglycemic events, suggesting IDet may be a safer option.
Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes.Herrera, KM., Rosenn, BM., Foroutan, J., et al.[2016]
In a non-inferiority trial involving 225 pregnant women with type 1 diabetes, insulin degludec was shown to be as effective as insulin detemir in controlling blood sugar levels, with similar HbA1c measurements before delivery.
Both insulins were found to have comparable safety profiles, indicating that degludec does not present additional safety concerns compared to detemir during 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.Mathiesen, ER., Alibegovic, AC., Corcoy, R., et al.[2023]

References

Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy. [2022]
Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. [2016]
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 analogs and pregnancy: an update. [2015]
Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. [2022]
Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. [2020]
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]
Safety of insulin analogs during pregnancy: a meta-analysis. [2022]
The care of pregestational and gestational diabetes and drug metabolism considerations. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Basal Analog Regimens in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Use of insulin pumps in pregnancies complicated by type 2 diabetes and gestational diabetes in a multiethnic community. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Correlates of Insulin Selection as a First-Line Pharmacological Treatment for Gestational Diabetes. [2023]
[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]
Fasting blood glucose predicts response to extended-release metformin in gestational diabetes mellitus. [2014]
[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]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security