Diabetes Mellitus, Type 2
Conditions
Brief summary
The hypothesis of this study is that using hospital admission to identify patients with poorly controlled diabetes (hemoglobin A1c levels \>8%), and intervening during the hospitalization with targeted inpatient diabetes management will improve glycemic control at 3 and 12 months, with inpatient glycemic control, quality of life, and diabetes self-efficacy serving as secondary endpoints.
Detailed description
The study is a randomized, controlled trial of targeted inpatient diabetes management versus usual care in 70 general medical and surgical inpatients over age 18 with type 2 diabetes and hemoglobin A1c levels greater than 8% who are followed in Partners-affiliated primary care practices. In addition, we will enroll a prospective chart review cohort matched for age, sex, and HbA1c level whose course we will follow for one year after discharge to determine the patter of glycemia among patients who are not enrolled in a clinical trial.
Interventions
OTHERDiabetes management team
MD evaluation followed by NP education and and medication titration
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Known diagnosis of type 2 diabetes by history with outpatient prescription of oral hypoglycemic medication or insulin * Hemoglobin A1c \> 8.0% within the prior 12 months, or if not known, fasting blood glucose greater than 200 mg/dl on sliding scale regular insulin. * Partners-affiliated primary care physician
Exclusion criteria
* Screening HbA1c returns less than 8%. * Diabetic ketoacidosis (DKA) as a primary reason for admission (admission blood glucose \> 250 mg/dl with arterial pH \< 7.30 or serum bicarbonate level \< 15 mg/dl), or development of DKA during admission. * Hyperosmolar hyperglycemic syndrome as a primary reason for admission (admission blood glucose \> 400 mg/dl and plasma osmolality \> 315 mOsm/kg. * Pregnancy, ruled out by urine HCG test at screening after consent is obtained in all women who continue to have menstrual cycles. * Anemia with hemoglobin \< 9 g/dl, recent blood transfusion, or need for blood transfusion (interferes with interpretation of hemoglobin A1c assay) * End stage liver disease with prothrombin time \> 15 seconds and albumin \<3 mg/dl * End stage renal disease: Stage IV (glomerular filtration rate \<30 mg/dl) or V chronic kidney disease * Treatment with corticosteroids * ICU transfer * Inability to self-administer insulin * Hypoglycemia unawareness: patient lacks sensation of common signs of blood glucose \< 60 mg/dl (tachycardia, diaphoresis, hunger, confusion, fatigue). * Projected survival \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6 months from discharge | Change in glycemic control measured by HbA1c change baseline to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Average Intervention Effect Over 12 Months After Hospital Discharge | 12 months from discharge |
Countries
United States
Participant flow
Recruitment details
April, 2009 to May 2010, recruited from inpatient medical and surgical general care (non-ICU) inpatient units
Participants by arm
| Arm | Count |
|---|---|
| Diabetes Management Team Evaluation and management by diabetes management team | 15 |
| Control Patients receive usual care for diabetes | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Control | Diabetes Management Team | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Continuous | 52.9 years STANDARD_DEVIATION 13.7 | 57.2 years STANDARD_DEVIATION 11.3 | 55 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 16 participants | 15 participants | 31 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 2 / 16 |
Outcome results
Primary
Hemoglobin A1c
Change in glycemic control measured by HbA1c change baseline to 6 months
Time frame: 6 months from discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Management Team | Hemoglobin A1c | -1.3 HbA1c, % | Standard Deviation 2.3 |
| Control | Hemoglobin A1c | -0.4 HbA1c, % | Standard Deviation 1.1 |
Secondary
Average Intervention Effect Over 12 Months After Hospital Discharge
Time frame: 12 months from discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Management Team | Average Intervention Effect Over 12 Months After Hospital Discharge | -0.6 HbA1c, % | Standard Error 0.5 |
| Control | Average Intervention Effect Over 12 Months After Hospital Discharge | -0.6 HbA1c, % | Standard Error 0.5 |