A clinical trial: Comparison of two insulin increasement methods in control of blood glucose in pregnant women with diagnosed diabetes on insulin therapy after betamethasone administration due to threatened preterm labor entering Mahdie hospital between 2021-2022: sliding method with increasing patient’s baseline insulin method

Average blood sugar in participants after betamethasone treatment in both groups Comparison of increased units of insulin in both groups Comparing blood sugar control in both groups Comparing maternal hypoglycemia episodes in two groups Comparing number of diabetic ketoacidosis mothers in both group

A parallel double blind randomized clinical trial, phase 2 that is enrolled for 34 pregnant patients who are diabetic and on insulin therapy. For randomization we use block randomization.

Study is conducted on insulin-treated diabetic pregnant women who enter and admit in Mahdie hospital with preterm labor and receive betamethasone, insulin dose regulation is done with either sliding or base adjustment method.

Gestational age between 24 to 34 weeks/ Gestational diabetes or Diabetes type 1 or 2 on insulin therapy/ completely controlled blood sugar before entrance to trial/corticosteroid therapy before labor Exclusion criteria: patient unwilling to continue the study or admission in our hospital.

After betamethasone injection, people will be divided in two groups randomly, to the first group, Basal long acting insulin will be increased by 20%, 30%, 30%, 20% and 10% respectively and blood sugar chart is as Fasting blood sugar, premeal and 1 hour post prandial and at 12 and 3 am. For the control group, insulin therapy will continue like before but blood sugar is charted hourly after 12 hours of betamethasone injection. Urinary ketone is assayed daily and if blood sugar is above 180, another urine sample is assayed and recorded. Average blood sugar of each person and extra insulins are recorded.

Patients blood sugar/ increase insulin dosage in both groups

Block Randomization Permuted: Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. Blocking is done in two ways: In the first method, the size of all blocks is equal (for example, in a two-group experiment, 8 blocks consist of 4 participants in the intervention group and 4 participants in the control group). In the second method, the size of all blocks is randomly selected (for example, blocks of 8, 6, 10, and 14 in which there are equal numbers of each group in each block). One of the potential problems in the blockchain method is the disclosure of the last allocation in each block. This problem occurs when the study uses the block-blocking method with fixed blocks and also does not use blinding. For example, in blocks of 4, where two allocations to the intervention group and two allocations to the control group are considered, the last allocation will be predictable when the first three allocations are revealed during sampling. Of course, this problem will be solved by randomly selecting the size of the blocks. For example, Hollingworth et al. Used random blocks 2, 4, or 6 for blocking, while Wong et al. Used only 6 blocks in their study.

The study is double-blind, and the patient and the nurse who injects the patient with insulin are unaware of which group the patient belongs to. Written consent will be obtained from all patients to participate in the study. Patients are then divided into two random groups and will not be informed which group they are in. Given that the medication received by the patient in the two groups will not change from before and only the insulin dose adjustment is different in the two study groups, the patient is aware that his blood sugar will be controlled with insulin (the patient has already used insulin to control blood sugar). However, the dose of insulin received and the method of increasing it will not be announced to them each time they receive the drug.

All results and IPD collected for the primary outcome measure will be shared.

6 month after publication

Data is available for people working in academic institutions.

After getting permission from the researcher, data could be used for meta-analysis.

Via Fateme Samadi Nasab's Email address

An Email must be sent to the researcher in Persian or English and the need for data and analysis must be explained.