Diabetes Type 2 on Insulin, Hyperglycemia Due to Type 2 Diabetes Mellitus, Hypoglycemia (Diabetic)
Conditions
Brief summary
The study compares two current practices for calculating insulin dose for admitted patients: flexible fixed mealtime dosing based on percent of meal eaten and carbohydrate counting based on amount of carbohydrates eaten.
Interventions
OTHERCarbohydrate-counting-based prandial rapid-acting insulin dosing
For each meal, the provider enters an insulin-to-carbohydrate ratio in the EHR. After the meal, nursing staff document the grams of carbohydrates consumed. The EHR calculates the rapid-acting insulin dose using the ordered insulin-to-carbohydrate ratio, along with any correctional insulin dose based on the pre-meal glucose value. The calculated insulin dose is then administered as soon as possible after meal completion.
OTHERFlexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed
For each meal, the EHR calculates a full fixed prandial rapid-acting insulin dose from the provider-entered insulin-to-carbohydrate ratio, assuming a full meal contains 75 grams of carbohydrates and rounding to the nearest whole-unit dose according to the protocol. After the meal, nursing staff document whether the participant consumed 0%, 25%, 50%, 75%, or 100% of the meal. The EHR then instructs nursing staff to administer the corresponding proportion of the fixed dose as soon as possible after meal completion.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years * Admitted to non-ICU units * Require scheduled prandial insulin as part of basal-bolus insulin therapy with CC.
Exclusion criteria
* History of type 1 DM * History of total pancreatectomy * Use of pre-admission CC for prandial insulin administration * Critical illness requiring ICU admission at time of recruitment. * Admission to psychiatry services * Pregnancy * All forms of enteral/tube feeding or parenteral nutrition at recruitment * Observation status at time of recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time With Glucose in Target Range of 100 to 180 mg/dL | From randomization to hospital discharge, up to 30 days | Patient-level percentage of time that glucose is within the target range of 100 to 180 mg/dL. This measure will be calculated using all glucose values obtained from randomization to discharge. For each patient, the time within range will be calculated using linear interpolation between consecutive measurements. For the percentage calculation, the numerator will be the calculated time within range, and the denominator will be the total time from the first glucose measurement after randomization to the last glucose measurement before discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hyperglycemia Events Greater Than 300 mg/dL | From randomization to hospital discharge, up to 30 days | Number of glucose values greater than 300 mg/dL from randomization to hospital discharge. |
| Rate of Hyperglycemia Events Greater Than 300 mg/dL Per Patient-Day | From randomization to hospital discharge, up to 30 days | Rate of glucose values greater than 300 mg/dL, calculated as the number of hyperglycemia events divided by the number of patient-days from randomization to hospital discharge. |
| Percentage of Time With Glucose Greater Than 300 mg/dL | From randomization to hospital discharge, up to 30 days | Patient-level percentage of time that glucose is greater than 300 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements. |
| Number of Hypoglycemia Events Less Than 70 mg/dL | From randomization to hospital discharge, up to 30 days | Number of glucose values less than 70 mg/dL from randomization to hospital discharge. |
| Rate of Hypoglycemia Events Less Than 70 mg/dL Per Patient-Day | From randomization to hospital discharge, up to 30 days | Rate of glucose values less than 70 mg/dL, calculated as the number of hypoglycemia events divided by the number of patient-days from randomization to hospital discharge. |
| Number of Severe Hypoglycemia Events Less Than 54 mg/dL | From randomization to hospital discharge, up to 30 days | Number of glucose values less than 54 mg/dL from randomization to hospital discharge. |
| Rate of Severe Hypoglycemia Events Less Than 54 mg/dL Per Patient-Day | From randomization to hospital discharge, up to 30 days | Rate of glucose values less than 54 mg/dL, calculated as the number of severe hypoglycemia events divided by the number of patient-days from randomization to hospital discharge. |
| Percentage of Time With Glucose Less Than 70 mg/dL | From randomization to hospital discharge, up to 30 days | Patient-level percentage of time that glucose is less than 70 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements. |
| Percentage of Time With Glucose Less Than 54 mg/dL | From randomization to hospital discharge, up to 30 days | Patient-level percentage of time that glucose is less than 54 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements. |
| Average Glucose During Hospitalization | From randomization to hospital discharge, up to 30 days | Mean glucose value during hospitalization, calculated using all point-of-care capillary and pertinent serum glucose values collected from randomization to hospital discharge. |
| Hospital Length of Stay | From randomization to hospital discharge, up to 30 days | Duration of hospitalization after randomization, reported in days |
| All-Cause 30-Day Hospital Readmission | Within 30 days after hospital discharge | Occurrence of all-cause hospital readmission within 30 days after hospital discharge. |
| All-Cause 30-Day Emergency Room Visit | Within 30 days after hospital discharge | Occurrence of an all-cause emergency room visit within 30 days after hospital discharge. |
| All-Cause Mortality | From randomization through 30 days after completion of study participation | Occurrence of death from any cause during study participation or within 30 days after completion of study participation. |
Contacts
CONTACTMelissa Wang
PRINCIPAL_INVESTIGATORSneha Mohan, MBBS
Mayo Clinic
Outcome results
None listed