Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Elderly, Insulin treatment, Quality of life
Brief summary
Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age \>65 years) with type 2 diabetes.
Interventions
DRUGInsulin Glargine
0.40 units/kg body weight
DRUGInsulin Aspart
0.20 units/kg body weight
DRUGInsulin Lispro
0.20 units/kg body weight
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Age \>65 years
Exclusion criteria
* Unable to provide informed consent * Enrollment in another research study * History of hypoglycemia unawareness * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) | 6 months | The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Any Hypoglycemia | 6 months | Defined as any reported blood glucose (BG) \<70 mg/dl will be compared between the two groups |
| Incidence of Severe Hypoglycemia | 6 months | Any BG \<54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multiple Subcutaneous Injection (MSI) MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
Insulin Glargine: 0.20 units/kg body weight
Insulin Aspart: 0.20 units/kg body weight
Insulin Lispro: 0.20 units/kg body weight | 3 |
| Basal Insulin (BI) BI group will receive only one injection of insulin glargine in the morning.
Insulin Glargine: 0.40 units/kg body weight | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Multiple Subcutaneous Injection (MSI) | Basal Insulin (BI) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| HbA1c | 9.9 % | 7.9 % | 8.6 % |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Hemoglobin A1c (HbA1c)
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Multiple Subcutaneous Injection (MSI) | Hemoglobin A1c (HbA1c) | 8.5 percentage of HbA1c |
| Basal Insulin (BI) | Hemoglobin A1c (HbA1c) | 7.8 percentage of HbA1c |
Secondary
Incidence of Any Hypoglycemia
Defined as any reported blood glucose (BG) \<70 mg/dl will be compared between the two groups
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multiple Subcutaneous Injection (MSI) | Incidence of Any Hypoglycemia | 0 participants |
| Basal Insulin (BI) | Incidence of Any Hypoglycemia | 0 participants |
Secondary
Incidence of Severe Hypoglycemia
Any BG \<54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multiple Subcutaneous Injection (MSI) | Incidence of Severe Hypoglycemia | 0 participants |
| Basal Insulin (BI) | Incidence of Severe Hypoglycemia | 0 participants |