Conditions: Type 1 Diabetes Hypoglycemia
Keywords: hypoglycemia type 1 diabetes split dosing insulin glargine continuous glucose monitoring
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief summary:
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level \<70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.

Detailed description:
Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients will continue to take their mealtime, short acting insulin doses.

Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked. Before the study, patients will be taught about how to use the CGM, and keep it taped to their abdomen. The site that the CGM inserts into their abdomen will need to be changed every 5 days. We will know if a patients' blood sugar goes low even if the patient did not feel the low. Patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the CGM.

Arms:
arm 1: Morning only administration of insulin glargine arm 2: Evening only administration of insulin glargine arm 3: Split dose administration of insulin glargine, half dose in morning, half dose in evening

Interventions: intervention 1: Evening only administration of insulin glargine intervention 2: Morning only administration of insulin glargine intervention 3: split dose insulin glargine
Intervention descriptions: intervention 1: Evening only administration of insulin glargine, with normal saline injection administered in the morning. intervention 2: Morning only administration of insulin glargine, with normal saline injection administered at night. intervention 3: split dose of insulin glargine, half administered in the morning, half administered in evening

Protocol document: