Hypoglycemia, Type 1 Diabetes
Conditions
Keywords
hypoglycemia, type 1 diabetes, split dosing insulin glargine, continuous glucose monitoring
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.
Interventions
DRUGEvening only administration of insulin glargine
Evening only administration of insulin glargine, with normal saline injection administered in the morning.
DRUGMorning only administration of insulin glargine
Morning only administration of insulin glargine, with normal saline injection administered at night.
DRUGsplit dose insulin glargine
split dose of insulin glargine, half administered in the morning, half administered in evening
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl) | 6 weeks |
| Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL. | 6 weeks |
Countries
United States
Participant flow
Recruitment details
This study was prematurely terminated because the P.I. is deceased. Although 16 participants were enrolled, however, the number of participants starting and completing the study as well as the number of participants assigned to each Arm/Group are unknown, since no data are available
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants were randomized to receive one of the three interventions: Insulin glargine only in the morning, Insulin glargine only in the evening, or a split dose of insulin glargine (half the dose in the morning and the other half in the evening). | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized Age, > 18 years old | 16 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.
Time frame: 6 weeks
Population: This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available
Primary
Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)
Time frame: 6 weeks
Population: This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available.