Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | March 2009 |
| End Date: | May 2010 |
| Contact: | Christopher D Saudek, MD |
| Email: | csaudek@jhu.edu |
| Phone: | 410-955-2132 |
Comparison of Glycemic Response to Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes Using Continuous Glucose Monitoring
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.
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.
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.
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.
Inclusion Criteria:
- Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus
- On multiple insulin injections, including a long acting or intermediate acting
insulin preparation and mealtime short acting insulin preparation.
- Clinical history consistent with hypoglycemia
- Hba1c <9.0%
Exclusion Criteria:
- Patients with type 2 diabetes mellitus
- Patients on insulin pump
- Poor control of diabetes (HbA1c > 9.0%)
- Pregnancy (women of childbearing age will undergo a pregnancy test at the start of
the study and will be advised to use birth control methods during the study). Insulin
glargine has been reported to have teratogenic effects in animal models, and
therefore should only be used during pregnancy if clearly needed.
- Serious co-morbidities that, in clinical opinion of the investigators, could affect
pharmacokinetics of glargine (e.g., CRF) or safety (e.g., recent CAD)
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