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Cited by 43Hyperglycemia and glycemic control in critically ill and hospitalized patientsDiabetes Management and ResearchDiabetes Treatment and Management

Comparison of Two Protocols in the Management of Glucocorticoid-induced Hyperglycemia among Hospitalized Patients

Open access
Lakhani, OmJ, Kumar, Surender, Tripathi, Sudhir, Desai, Mitali, Seth, Chandani·2017·Indian Journal of Endocrinology and Metabolism
DOI 10.4103/ijem.ijem_226_17PMC PMC5729670
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Abstract

Context: There is limited literature focusing on the management of glucocorticoid-induced hyperglycemia (GCIH). Aims: The primary objective was to compare the mean blood glucose between the experimental group (new protocol) and the control group (standard protocol) in the management of GCIH. The secondary objective was to compare other parameters of glycemic efficacy, variability, and safety parameters. Methods: This was a randomized, open-labeled, parallel arm trial. Adult patients who were given glucocorticoid (minimum dose equivalent to prednisolone 10 mg) in the past 24 h and had 2 h postmeal plasma glucose ≥200 mg/dl were included in the study. Patients randomized to control group received standard basal-bolus insulin. In the experimental group, a “correctional insulin” matching the glycemic profile of the glucocorticoid administered was provided with or without “background” basal-bolus insulin. The parameters of glycemic efficacy, variability, and safety were compared. P < 0.05 was considered statistically significant. Results: Data of 67 patients included in the study were analyzed, of which 33 patients were in the experimental group and 34 patients in the control group. The mean blood glucose in the experimental and the control group was 170.32 ± 33.46 mg/dl and 221.05 ± 49.72, respectively (P = 0.0001). The parameters for glycemic variability were all significantly lower in patients in the experimental group. The hypoglycemia event rate was low in both the groups. Conclusion: When compared to the standard basal-bolus insulin protocol, the new protocol showed lower mean blood glucose and lower glycemic variability.

AI snapshot

Written from the paper’s full text.

TL;DR

A randomized, open-label trial compared a new “correctional insulin” protocol matched to the administered glucocorticoid against standard basal-bolus insulin for glucocorticoid-induced hyperglycemia in hospitalized patients. The new protocol produced lower mean blood glucose and lower glycemic variability, with low hypoglycemia event rates in both groups.

Key findings

  • Mean blood glucose was lower in the experimental group than the control group: 170.32 ± 33.46 mg/dl vs 221.05 ± 49.72 mg/dl (P = 0.0001) in the abstract; the results text reports the control mean as 214.99 mg/dl.
  • All glycemic variability parameters assessed — SD of blood glucose, SD of premeal blood glucose, mean delta blood glucose, mean daily SD, and MAGE — were significantly lower in the experimental group.
  • Hypoglycemia event rates were low in both groups; no patient developed severe hypoglycemia, mortality, or diabetic ketoacidosis. Severe hyperglycemia event rate was significantly lower in the experimental group.
  • Percentages of readings in target range were higher in the experimental group, but only the percentage of premeal blood glucose in target range was statistically significant.

Methods

  • Single tertiary care institution in New Delhi; randomized, open-labeled, parallel-arm trial conducted August 2014 to April 2016. Adults ≥18 years, nonpregnant, with or without diabetes, who received systemic glucocorticoid at a minimum dose equivalent to prednisolone 10 mg in the past 24 h and had 2 h postmeal plasma glucose ≥200 mg/dl were included.
  • Of 3110 screened, 234 received glucocorticoids, 103 developed qualifying hyperglycemia, 92 were randomized, and 67 were analyzed (33 experimental, 34 control). Control received standard basal-bolus insulin; experimental received “correctional insulin” matched to the glucocorticoid type and dose, with background basal-bolus insulin for established diabetes (Group 1) and without background insulin for glucocorticoid-induced hyperglycemia (Group 2).
  • Capillary blood glucose was monitored four times daily; day 1 readings were excluded from analysis. Parametric data were compared with unpaired t-test, nonparametric with Mann–Whitney U-test, and categorical with Chi-square; P < 0.05 was significant.

Limitations

  • The paper states that too few patients received dexamethasone and hydrocortisone to draw conclusions from subgroup analysis, and that insulin dose data were not collected in either group.
  • Evident from the text: the study was single-center and open-label, and although 92 patients were randomized, only 67 were analyzed after exclusions.
  • Evident from the text: baseline preexisting diabetes differed between groups (42% experimental vs 64% control, P = 0.08), and the abstract and results report different control mean blood glucose values (221.05 vs 214.99 mg/dl).

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.4103/ijem.ijem_226_17

Cites

28 of 28 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 25 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    No mortality was reported in either group during the study period.

    “No mortality was reported in either of the two groups during the study period.”
    Quote in the paperNot a substantial claim
  • Findingown data

    The hypoglycemia event rate was low in both groups.

    “The hypoglycemia event rates (hypoglycemia defined by blood glucose <70 mg/dl) were low in both the groups [Table 12].”
    Quote in the paperNot a substantial claim
  • Findingown data

    The event rate for severe hyperglycemia (blood glucose >300 mg/dl) was significantly lower in the experimental group.

    “The event rate for severe hyperglycemia (defined as blood glucose >300 mg/dl) was significantly lower in the experimental group [Table 12].”
    Quote in the paperSubstantial claim
  • Findingown data

    Mean blood glucose was significantly lower in the experimental group than in the control group.

    “The mean blood glucose in the experimental and the control group was 170.32 ± 33.46 mg/dl and 221.05 ± 49.72, respectively (P = 0.0001).”
    • Also stated in: § Comparison of parameters of glycemic efficacy between experimental and control groups · plain
      “The mean blood glucose in the experimental group was 170.32 mg/dl while that in the control group was 214.99 mg/dl.”
    Quote in the paperSubstantial claim
  • Findingown data

    No patient in either group developed diabetic ketoacidosis during the study.

    “No patients in either of the two groups developed diabetic ketoacidosis during the study.”
    Quote in the paperNot a substantial claim
  • May combine two claims. 12
  • Classified as probably not a substantial claim. 16

  • May combine two claims.

    Findingown data

    The percentages of blood glucose readings in target range were higher in the experimental group, but only the percentage of premeal blood glucose in target range was statistically significantly different.

    “The parameters which assessed the blood glucose in target ranges were higher in the experimental group. However, except for the percentage of premeal blood glucose in target range, the differences were not statistically significant.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Glycemic variability parameters (SD of blood glucose, SD of premeal blood glucose, mean delta blood glucose, mean daily SD, and MAGE) were all significantly lower in the experimental group.

    “The parameters for glycemic variability (SD of blood glucose, SD of premeal blood glucose, mean delta blood glucose, mean daily SD, and MAGE) were all significantly lower in patients in the experimental group [Table 11].”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Mean fasting, prelunch, predinner, bedtime, and premeal blood glucose readings were all significantly lower in the experimental group.

    “The mean blood glucose and all the other blood glucose readings including fasting, prelunch, predinner, bedtime, and premeal overall were all significantly lower in experimental group [Table 10 and Figure 2].”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The proportion of patients receiving prednisolone versus glucocorticoid other than prednisolone was not statistically significant between the two groups (P = 0.22).

    “However, the proportion of patients receiving prednisolone versus glucocorticoid other than prednisolone was not statistically significant between the two groups (P = 0.22).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Data on insulin dose used in the experimental and control groups were not collected.

    “We did not collect data for the dose of insulin used in the experimental and control group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    During follow-up, 10 patients in the experimental group and 11 patients in the control group were excluded.

    “On follow-up during the hospital stay, 10 patients in the experimental group and 11 patients in the control group were excluded.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Capillary blood glucose monitoring was carried out four times a day using a glucometer, and hospital glucometers were from the same manufacturer and regularly calibrated.

    “In all cases, capillary blood glucose (CBG) monitoring was carried out four times a day (three times before meals and at bedtime) using a glucometer. Our hospital uses glucometers from the same manufacturer in all the wards and it is regularly calibrated.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Glucocorticoids cause hyperglycemia through enhanced hepatic gluconeogenesis, increased peripheral insulin resistance, and inhibition of peripheral glucose uptake by skeletal muscles.

    “Glucocorticoids enhance the hepatic gluconeogenesis, and they cause an increase in the peripheral insulin resistance. They also cause degradation of proteins and lipids providing the substrate for gluconeogenesis.[910] The inhibition of peripheral glucose uptake by skeletal muscles is seen early after administration of glucocorticoids. This explains the reason that glucocorticoids cause initial”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [9] Kuo, 2015, Adv Exp Med Biol

      Not checked in the free run.

    • cites [10] van, 2014, Neth J Med

      Not checked in the free run.

    • cites [11] Tamez-Pérez, 2015, World J Diabetes

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    All patients received the allocated intervention.

    “All patients received the allocated intervention.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisecitation

    The dose of NPH insulin should be based on the dose of prednisolone administered and the weight of the patient.

    “They also recommended that the dose of the insulin NPH should be based on the dose of the prednisolone administered and weight of the patient.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [12] Burt, 2011, J Clin Endocrinol Metab

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The trial was open-labeled.

    “This was a randomized, open-labeled, parallel arm trial.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing).

    Premisecitation

    If a specific insulin is given simultaneously with glucocorticoid administration, it can negate the hyperglycemic effect of the glucocorticoid.

    “The basis of the second school of thought is that if we can give a specific insulin simultaneously with the glucocorticoid administration, we would be able to negate the hyperglycemic effect of the glucocorticoid.[15]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Perez, 2014, J Diabetes

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Premisecitation

    The insulin used to neutralize the glucocorticoid should have the same peaks and duration of action as the hyperglycemic effect of the glucocorticoid.

    “The authors have proposed that the type of insulin we would use for neutralizing the glucocorticoid should have the same peaks and duration of action as the hyperglycemic effect of the glucocorticoid.[14]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] Clore, 2009, Endocr Pract

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    64% of hospitalized patients who received glucocorticoids equivalent to prednisolone ≥40 mg developed hyperglycemia.

    “A study revealed that 64% of indoor patients who received glucocorticoids equivalent to prednisolone ≥40 mg developed hyperglycemia.[2]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [2] Donihi, 2006, Endocr Pract

      Not checked in the free run.

  • May combine two claims.

    Study design and conductreasoning

    The calculated sample size was 23 per group (total 46); 92 patients were enrolled to improve power, giving 99% power with an alpha error of 0.05.

    “We used the data from the pilot study conducted by Seggelke et al.[4] for calculating our sample size. The calculated sample size was 23 for each group (total of 46). However, to improve the power of the study, we had decided to enroll 92 patients (double the calculated sample size). This gave our study a power of 99% with an alpha error of 0.05.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [4] Seggelke, 2011, J Hosp Med

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Dexamethasone has a longer half-life than other glucocorticoids; its glycemic effect starts about 3 h, peaks around 9-10 h, and may last as long as 48 h.

    “It is well known that dexamethasone has a longer half-life than other glucocorticoids.[21] Sethi et al.[22] demonstrated that the glycemic effect of dexamethasone starts in about 3 h. Eberhart et al.[23] and Lukins and Manninen[24] showed that glycemic peak due to dexamethasone is at around 9–10 h after administration. The glycemic effect of dexamethasone may last as long as 48 h.[20]”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [21] Czock, 2005, Clin Pharmacokinet

      Not checked in the free run.

    • cites [22] Sethi, 2016, Asian J Neurosurg

      Not checked in the free run.

    • cites [23] Eberhart, 2011, Eur J Anaesthesiol

      Not checked in the free run.

  • May combine two claims.

    Study design and conductown data

    The proportion of patients with preexisting diabetes mellitus was 42% in the experimental group and 64% in the control group, and the difference was not statistically significant (P = 0.08).

    “Forty-two percent of patients in the experimental group and 64% patients in the control group had preexisting diabetes mellitus. Although the proportion of patients with preexisting diabetes in the experimental and control group was different, the difference was not statistically significant (P = 0.08).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Hydrocortisone has a shorter half-life than other glucocorticoids and produces a glycemic peak 2 h after administration in healthy volunteers.

    “Hydrocortisone has a much shorter half-life as compared to other glucocorticoids. Vila et al.[25] showed that hydrocortisone produced a glycemic peak 2 h after administration in healthy volunteers.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [25] Vila, 2010, Eur J Endocrinol

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    The new protocol's basis is that giving an additional correctional insulin matching the glycemic profile of the glucocorticoid administered would negate the glycemic effect of the glucocorticoid.

    “The basis of this protocol is that giving an additional “correctional insulin” which matches the glycemic profile of the glucocorticoid administered would negate the glycemic effect of the glucocorticoid.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [14] Clore, 2009, Endocr Pract

      Not checked in the free run.

    • cites [15] Perez, 2014, J Diabetes

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Clore and Thurby-Hay proposed that morning glucocorticoid causes insulin resistance throughout the day rather than a specific postprandial defect.

    “However, Clore and Thurby-Hay[14] proposed that the reason for the phenomenon was probably the effect of morning glucocorticoid in causing insulin resistance throughout the day, rather than specific a postprandial defect.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] Clore, 2009, Endocr Pract

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Patients were randomized to the control or experimental group using computer-generated random numbers.

    “On recruitment, the patients were randomized to either the control group or the experimental group using computer-generated random numbers.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The new protocol had fewer episodes of severe hyperglycemia and a negligible risk of hypoglycemia.

    “The new protocol had lesser episodes of severe hyperglycemia, and the risk of hypoglycemia was negligible.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The Endocrine Society does not endorse the NPH-with-prednisolone protocol because of lack of evidence.

    “The Endocrine Society, however, does not endorse this protocol because of lack of evidence.[5]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Umpierrez, 2012, J Clin Endocrinol Metab

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Data from 67 patients (33 experimental, 34 control) were analyzed.

    “After all the exclusions, data of 34 patients in the control group and 33 patients in the experimental group were analyzed.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    Data from day 1 of randomization were excluded from calculation of glycemic parameters.

    “Data from day 1 of randomization were not used to calculate any of the parameters mentioned below because the patient would be still in a titration phase on day 1.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    The basal-bolus insulin approach for GCIH is well established and superior to sliding-scale insulin.

    “The use of this basal-bolus insulin approach for GCIH is well established, and there is evidence that it is superior to sliding-scale insulin which was used in the past.[13]”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Gosmanov, 2013, Endocr Pract

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The Australian Diabetes Society and Joint British Diabetes Societies guidelines endorse protocols using NPH with morning prednisolone.

    “The guidelines by Australian Diabetes Society[16] and a recent guideline by the Joint British Diabetes societies[18] endorse similar protocols.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [16] Chipps D, Cornelius S, Depczynski B, Heels K, O'Neal D, Wong J, et al. ADS Guidelines for Routine Glucose Control In Hospital; 2012. Available from: https://www.diabetessociety.com.au/documents/ADSGuidelinesforRoutineGlucoseControlinHospitalFinal2012_000.pdf. [Last accessed on 2016 Nov 10].

      Not checked in the free run.

    • cites [18] Roberts A, James J, Dhatariya K. Management of Hyperglycaemia and Steroid (Glucocorticoid) Therapy; 2014.

      Not checked in the free run.

27 of 27

  • The paper relies on this without support.

    Regular human insulin has a peak effect after 2 h.

    “Since regular human insulin has peak after 2 h, it is perfect insulin to be administered along with hydrocortisone.”

  • The paper relies on this without support.

    Insulin glargine has a longer half-life and longer duration of effect than other insulins, making it suitable for administration with dexamethasone.

    “Insulin glargine has a longer half-life and a longer duration of effect, and hence, it is a more suitable insulin to administer with the dexamethasone.”
2 of 2

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Control-group mean blood glucose differs between abstract and results

    Major

    The abstract reports the control-group mean blood glucose as 221.05 mg/dl, while the results report 214.99 mg/dl for the same group and outcome.

  • Two different bedtime glucose target ranges are specified

    Minor

    The methods assign bedtime glucose both a 100-140 mg/dl target and a 140-180 mg/dl target, leaving the target used for bedtime readings unclear.

2 of 2

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Related

Authors
Lakhani, O., Kumar, S., Tripathi, S., Desai, M., & Seth, C.
Affiliations
Sir Ganga Ram Hospital (IN)
ORCID
Kumar, Surender
Venue
Indian Journal of Endocrinology and Metabolism
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2017
Volume
21
Issue
6
Pages
836
ISSN
2230-8210 (ISSN-L)
DOI
10.4103/ijem.ijem_226_17
PMC
PMC5729670
OpenAlex
W2770574068
Semantic Scholar
71cc531bef42d9d65662fe37278f0728dbe1a448
Cited by
43
References
28
Citations by year
2026: 5 · 2025: 2 · 2024: 7 · 2023: 1 · 2022: 11 · 2021: 5 · 2020: 3 · 2019: 5 · 2018: 4
FWCI
2.60
Type
journal article
Language
en
Open access
Licence
cc-by-nc-sa
Locations
  • Indian Journal of Endocrinology and Metabolism (publishedVersion, cc-by-nc-sa)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
  • PubMed Central (publishedVersion, cc-by-nc-sa)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
glucocorticoid-induced hyperglycemia, multiple daily insulin injections, glycemic variability, glycemic control, hypoglycemia, hospitalized patients, prednisolone

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