Admitting Hospital, Diabetes, Non-critically Ill
Conditions
Keywords
diabetes, glucose, hospital
Brief summary
The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.
Detailed description
The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.
Interventions
DRUGAspart fixed dose
fixed dose
DRUGAspart flexible dose
dose based upon carbohydrate intake and total daily requirements
Sponsors
Novo Nordisk A/S
Kathleen Dungan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* general medical or minor surgical hospitalized patients * type 2 diabetes * blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment
Exclusion criteria
* • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours). * Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds. * Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing. * Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely * Prolonged (\>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable. * Patients for whom expected length of stay will be less than 48 hours * Patients using subcutaneous insulin pumps * Diabetic ketoacidosis * End-stage renal disease on dialysis * End-stage liver disease with cirrhosis * Mental conditions precluding informed consent * Potentially sensitive admissions: prisoners, HIV, suicidality * Unable to give consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Glucose | day 3 | Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glucose | day 3 | Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3. |
| Hypoglycemia | 72 hour | Number of patients with any hypoglycemic event (\<70 mg/dl or \<40 mg/dl) |
| Change in Glucose | 72 hour | Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1. |
| Treatment Satisfaction | day 3 | treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score. |
| 1,5-anhydroglucitol Change | day 1 to day 3 | change in short-term measure of glycemia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flexible Dose aspart dose determined based upon carbohydrate intake. | 63 |
| Fixed Dose fixed meal dose of aspart (based upon weight or total daily insulin dose) | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | Fixed Dose | Flexible Dose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 15 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 48 Participants | 97 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 63 participants | 63 participants | 126 participants |
| Sex: Female, Male Female | 29 Participants | 25 Participants | 54 Participants |
| Sex: Female, Male Male | 34 Participants | 38 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 62 | 14 / 59 |
| serious Total, serious adverse events | 0 / 62 | 0 / 59 |
Outcome results
Primary
Mean Glucose
Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3
Time frame: day 3
Population: Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible Dose | Mean Glucose | 158 mg/dl | Standard Deviation 47 |
| Fixed Dose | Mean Glucose | 171 mg/dl | Standard Deviation 49 |
Secondary
1,5-anhydroglucitol Change
change in short-term measure of glycemia
Time frame: day 1 to day 3
Population: subjects with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible Dose | 1,5-anhydroglucitol Change | 0.41 mcg/ml | Standard Deviation 2.76 |
| Fixed Dose | 1,5-anhydroglucitol Change | 0.73 mcg/ml | Standard Deviation 3.96 |
Secondary
Change in Glucose
Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.
Time frame: 72 hour
Population: intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible Dose | Change in Glucose | -4.2 mg/dl | Standard Deviation 35 |
| Fixed Dose | Change in Glucose | -8.1 mg/dl | Standard Deviation 54 |
Secondary
Hypoglycemia
Number of patients with any hypoglycemic event (\<70 mg/dl or \<40 mg/dl)
Time frame: 72 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible Dose | Hypoglycemia | 24 participants |
| Fixed Dose | Hypoglycemia | 14 participants |
Secondary
Postprandial Glucose
Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.
Time frame: day 3
Population: Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible Dose | Postprandial Glucose | 175 mg/dl | Standard Deviation 51 |
| Fixed Dose | Postprandial Glucose | 203 mg/dl | Standard Deviation 74 |
Secondary
Treatment Satisfaction
treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.
Time frame: day 3
Population: all participants who completed the survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible Dose | Treatment Satisfaction | 69 points on a scale | Standard Deviation 14 |
| Fixed Dose | Treatment Satisfaction | 68 points on a scale | Standard Deviation 13 |