Diabetes Mellitus, Type 2
Conditions
Brief summary
A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.
Detailed description
The purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes. The objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, GI effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.
Interventions
DRUGMetformin
Continuation of home metformin
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, parallel, prospective trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Adult (18+ years of age) * Admitted to an internal medicine service. * On Metformin prior to admission.
Exclusion criteria
* Inability to take oral medications * eGFR \< 30 ml/min/1.73 m2 * Dialysis * Current Acidosis (pH \< 7.35) including diabetic ketoacidosis * Child-Turcotte-Pugh class C hepatic cirrhosis * Acute Decompensated Heart Failure * Cognitively impaired and/or unable to consent * Lack of or unwillingness to share contact information * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose levels | During hospitalization | Average of daily glucose levels during hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hyperglycemia greater than 300 mg/dl. | During hospitalization | Glucose \> 300 |
| Incidence of hypoglycemia (Glu = 54 - 70). | During hospitalization | Glu = 54 - 70 |
| Incidence of moderate hypoglycemia (Glu < 54) | During hospitalization | Glu \< 54 |
| Incidence of severe hypoglycemia (Glu < 54 with symptoms) | During hospitalization | Glu \< 54 with symptoms |
| Mean lactic acid levels. | During hospitalization | Mean lactic acid levels |
| Incidence of lactic acid levels greater than 2.0. | During hospitalization | Lactic acid \> 2.0 |
| Mean anion gap. | During hospitalization | Mean anion gap, a calculated value |
| Incidence of anion gap > 11 | During hospitalization | Anion Gap \> 11 |
| Incidence of elevated lactic acid level or anion gap. | During hospitalization | Lactic acid \> 2.0 or Anion Gap \> 11 |
| Incidence of inadvertently not continuing metformin on discharge | At discharge | Transitions of care |
| GI adverse effects | Within 3 days of discharge | GI side effects after discharge |
| Mortality | 30 +/- 3 days after discharge | Mortality as determined via chart search and follow up phone call |
Countries
United States
Outcome results
None listed