Purpose: To find comparative beneficial treatment from either lispro insulin or minimally invasive lispro insulin therapy on primary and secondary outcomes in gestational diabetes mellitus (GDM) patients.
Methods: The present study was carried out on GDM patients enrolled in minimally invasive lispro insulin treatment group with hollow microneedle inserted 1 mm under skin and another group of lispro insulin therapy. In present study, 65 females with GDM enrolled for treatment with minimally invasive therapy at 8th-12th week after conception. Hospital Records of the past 10 years was used to abstract data for insulin treatment to GDM patients. Data of 100 GDM subjects treated with insulin therapy was included. The primary outcomes monitored include composite outcomes, hypoglycemia, respiratory distress, need of phototherapy and birth injury. Changes in blood glucose and complications in GDM patients were secondary outcomes.
Results: The primary endpoints in minimally invasive lispro insulin treatment group as compared to lispro insulin treatment GDM subjects were slightly ameliorated but statistically insignificant to find any conclusion. Minimally invasive insulin therapy results in lower neonatal composite complications as compared to insulin therapy but is not significant. The GDM hypertension and maternal glycemic control were significantly ameliorated in Group II than Group I.
Conclusion: The minimally invasive lispro insulin therapy significantly ameliorated secondary outcomes as compared to lispro insulin treatment in GDM subjects. Ironically, a primary outcome in GDM patients with minimally invasive lispro insulin therapy and lispro insulin treatment was statistically indifferent.