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Journal Club: Inpatient Management of T2DM

RABBIT 2 Trial and Bolus Plus Trial
by

Belal Firwana

on 21 January 2015

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Transcript of Journal Club: Inpatient Management of T2DM

RA
ndomized Study of
B
asal
B
olus Insulin Therapy in the
I
npatient Management of Patients with
T
ype
2
Diabetes
Inpatient Management of Patients with Type 2 Diabetes (RABBIT 2 and Basal Plus Trials)
Background
Methods
Results
Randomized Study Comparing a Basal-Bolus With a
Basal Plus
Correction Insulin Regimen for the Hospital Management of Medical and Surgical Patients With Type 2 Diabetes
Background
Methods
Results
Belal Firwana
Rim Hasan

RABBIT 2 Trial
Basal Plus Trial
Diabetes Care. 2013 Aug ; 36 : 2169-74
Diabetes Care. 2007 Sep; 30 : 2181-6
Patients
INCLUSION:

Nonsurgical, insulin-naive patients.
Known hx of T2DM for >3 months.
BG level between 140 and 400 mg/dl.
Diabetes treatment with either diet alone or oral hypoglycemics.
Absence of diabetic ketoacidosis

Interventions
Outcomes
Glargine QD
Glulisine AC
Basal-bolus
Sliding Scale
Primary:

mean daily blood glucose

Secondary:

hypoglycemic events
severe hyperglycemia
length of hospital stay
Changes in BG in patients treated with glargine plus glulisine (•)
and with SSI (0). *P < 0.01; ¶P < 0.05
Mean blood glucose in
9
subjects who remained with severe hyperglycemia despite increasing doses of regular insulin per the sliding-scale protocol (0)
The mean daily glucose difference between groups ranged from 23 to 58 mg/dl during days 2–6 of therapy

The percentage of patients within the mean glucose target (<140 mg/dl) was 66% in patients treated with glargine and glulisine versus 38% in those treated with SSI

Hypoglycemia (defined as blood glucose <60 mg/dl) occurred in two patients in each treatment group (P = NS).

The mean hospital length of stay was 5.3 ± 6 days in patients treated with basal-bolus and 5.1 ± 4 days in the SSI-treated group (P = NS).
Discussion
Limitations:

Excluded patients without known history of diabetes before admission, whom represent about one third of hospitalized patients with hyperglycemia.

Excluded patients treated with insulin and corticosteroids as they are at higher risk of severe hyperglycemia if treated with SSI

The study was not powered to demonstrate differences in mortality or clinical outcome between treatment groups.
Clinical practice guidelines have recommended the use of the
basal-bolus approach as the preferred insulin regimen
for the management of patients with diabetes not in the ICU

Despite the benefits of a basal-bolus regimen, many health care providers are reluctant to integrate this approach into their clinical practice, probably because of its complexity and a fear of hypoglycemia
Because most patients in the hospital have reduced caloric intake as a result of medical illness or surgical procedures, it was hypothesized that a
single daily dose of basal insulin might result in similar glucose control and lower the rate of hypoglycemia relative to a basal-bolus
regimen
Objective
To test the efficacy and safety in general medical and surgical patients with T2D of a daily dose of basal insulin plus corrective doses with a rapid-insulin analog given by sliding scale (basal plus regimen) with a basal-bolus insulin regimen with glargine once daily and fixed doses of glulisine before meals and also with SSI (no basal insulin) given four times
Objective
A prospective, randomized study, conducted to compare the efficacy and safety of a basal-bolus insulin regimen with that of SSI in patients with type 2 diabetes admitted to general medicine wards.
Patients
375 adult patients
Known history of T2D
BG 140 and 400 mg/dL
T2D Tx with diet alone, oral hypoglycemics or low-dose insulin (<0.4 units/kg/day)
Outcomes
Primary:
Mean daily BG

Secondary:
Hypoglycemic events (<70, <40)
Hyperglycemia episodes (>200)
TDD of insulin
Hospital stay
Hospital complications
Basal-bolus
SSI
Basal plus
Lantus adjustments: in patients >70 years of age and those with a serum creatinine >2.0 mg/dL, the starting TDD in the basal-bolus group was reduced to 0.3 units/kg in the basal-bolus, and TDD of glargine was reduced to 0.15 units/kg in the basal plus regimen.

The goal of insulin therapy was to maintain fasting and premeal glucose concentrations between 100 and 140 mg/dL
Interventions
Differences in glycemic control in medical and surgical patients with T2D treated with basal-bolus (•) and basal plus (0) regimens
Discussion
Treatment with basal plus resulted in:

Similar improvement in mean daily BG to the basal-bolus regimen.

No difference in the number of treatment failures and similar numbers of hypoglycemic events.

Both regimens had better glycemic control and fewer treatment failures than did treatment with SSI.
EXCLUSION:

No known history of diabetes.
ICU.
Use of corticosteroid therapy.
Expected surgery during hospitalization.
Clinically relevant hepatic disease.
Creatinine >3.0 mg/dl.
Pregnancy
Mental condition - unable to understand the scope and consequences of the study

All patients were managed by members of the internal

medicine residency program
, who received a copy of the assigned treatment protocol.

A teaching

endocrinologist rounded daily
with the house officers

No follow-up visit after discharge was included in this study.
EXCLUSION:
BG >400 mg/dL before randomization
History of hyperglycemic crises
Hyperglycemia without a known history of diabetes
Admitted to or expected to require ICU admission
Cardiac surgery
Receiving corticosteroid therapy
Clinically relevant hepatic disease
Impaired renal function (Cr >3.0 mg/dL)
History of diabetic ketoacidosis
Pregnant patients
Mental condition rendering them unable to give informed consent.
Compared to basal-bolus, SSI was associated with (P < 0.01):

↑ mean fasting gluc

(165 ± 41 vs. 147 ± 36 mg/dl)
↑ mean random gluc
(189 ± 42 vs. 164 ± 35 mg/dl)
↑ mean gluc during hospital stay
(193 ± 54 vs. 166 ± 32 mg/dl).
↑ mean gluc during last hospitalization day

(187 vs. 140 mg/dl)
LIMITATION:

Excluded patients admitted to ICU, patients with hepatic disease, Cr >3.0 mg/dL, severe hyperglycemia, and those receiving a TDD of insulin >0.4 units/kg/day before admission.
>>> For such patients, higher insulin doses or a standard basal-bolus approach may be the preferred approach in achieving glycemic control.

Study was not powered to determine differences in hospital complications across groups.
>>> A RABBIT 2 surgical trial, reported a significant reduction in the frequency of hospital complications in patients treated with a basal-bolus regimen compared with SSI treatment.
Magaji et. al. Clinical Diabetes. Jan 2011 vol. 29 no. 1 3-9
Baseline characteristics
If the mean daily BG level was >240 mg/dl, or if three consecutive values were >240 mg/dl on the maximal SSI dose, patients were switched to a basal-bolus regimen starting at a TDD of 0.5 units/kg
Treatment with insulin glargine and glulisine resulted in significant improvement in glycemic control compared with that achieved with the use of SSI alone.

The study indicates that a basal-bolus insulin regimen is preferred over SSI in the management of non–critically ill, hospitalized patients with type 2 diabetes.
Take home message ...
Hyperglycemia

during acute medical illness is not a physiologic or benign condition, but it is
associated with increased risk
of

prolonged hospital stay
,
infection
,
disability
after hospital discharge and mortality.

Effective management
of hyperglycemia
reduces the risk
of multiorgan failure, systemic infections, and short- and long-term mortality, and it is associated with a decreased length of intensive care unit and hospital stay.
Hypothesis
The difference in mean daily BG between basal plus and basal-bolus would be no greater than 18 mg/dL (1 mmol/L).
Hyperglycemia .......

Insulin, IV or SQ, the most effective agent for immediate control of hyperglycemia in the hospital

In the
critical care
setting,
continuous insulin infusion
protocols have been shown to be effective in achieving glycemic control, with a low rate of hypoglycemic events

In
general medicine services
,
hyperglycemia is frequently overlooked
and inadequately addressed.
Reports from academic institutions have shown that

most patients are treated with SSI
and that basal insulin is prescribed in less than one-half of patients.
In general surgery patients, the
relative risk for serious postoperative infections
(sepsis, pneumonia, and wound infection) increased 5.7-fold when any postoperative day 1 blood glucose was >220 mg/dl
What if .....
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