Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

Group assignment will be randomized by computer program.

It had two arms (groups): combined metformin and insulin (active comparator) and Insulin only (other).

The registry classes the interventions as drug.

More on the Plan

Fetal weight gain weekly 2.

Maternal weight gain weekly Accordingly: 1.

Uncontrolled cases will follow up weekly in the High Risk Pregnancy outpatient clinic until 36 weeks and then admitted to High risk pregnancy department for termination of pregnancy o Fetal surveillance will be done by ;CTG weekly, Ultrasound weekly and Fetal kick count daily 2.

Fasting blood sugar , 2 hours post prandial blood sugar and HBA1C 2.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diabetic pregnant patients with type one diabetes and no other chronic disorders. Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start of gestation). Patients pregnant in single living fetus with no apparent congenital anomalies. All patients have done a dating ultrasound to confirm gestational age, viability and rule out any abnormality.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: patients with type 2 or gestational diabetes; patients with intolerance or hypersensitivity to metformin; patients with congestive heart failure or a history of congestive heart failure.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-04-29 with completion listed for 2020-03-29.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: 12 weeks). capillary glucose (time frame: 12 weeks). fasting blood sugar measurement (time frame: 12 weeks).

It also tracked 10 secondary outcomes, for example Maternal weight gain, weekly fetal weight gain measured by ultrasound, insulin requirements, attacks of maternal hypoglycemia, neonatal weight and preterm birth.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.