Trial · NCT00353431

Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

NCT00353431, Not applicable, Completed, University Hospital, Basel, Switzerland; results first posted 2012-05-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia. Trials, record NCT00353431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00353431

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
NCT number: NCT00353431
Status: Completed
Phases: Not applicable
Enrollment: 130 participants, actual
Lead sponsor: University Hospital, Basel, Switzerland
Conditions: Hyperglycemias
Interventions: Novorapid ®, Novo Nordisk, Denmark
First posted: 2006-07-18
Last updated: 2012-05-18
Other registries' IDs: isrctn:ISRCTN55224894
Results first posted: 2012-05-08
Limitations and caveats: Small sample size

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	48 h	Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)
Secondary	Time to Reach the Target Range	24 h	Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).
Secondary	Frequency of Hypoglycemia	during observation of 48 hours	absolute number of participants with hypoglycemia (plasma glucose \< 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)
Secondary	Frequency of Severe Hypoglycaemia	during observation of 48 hours	Number of participants with severe hypoglycaemia (plasma glucose \< 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)
Secondary	Frequency of Hypokalaemia	during observation of 48 hours	Number of participants with hypokalaemia (potassium \< 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	48 h	Intension to treat	hours	MEAN
SECONDARY	Time to Reach the Target Range	24 h	Intension to treat	hours	MEAN
SECONDARY	Frequency of Hypoglycemia	during observation of 48 hours		participants	NUMBER
SECONDARY	Frequency of Severe Hypoglycaemia	during observation of 48 hours		participants	NUMBER
SECONDARY	Frequency of Hypokalaemia	during observation of 48 hours		participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	Conventional Insulin Group	13.0	Standard Deviation 14.7	hours
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	Intensive Insulin Therapy Algorithm	22.5	Standard Deviation 10.5	hours
Time to Reach the Target Range	Conventional Insulin Group	24.3	Standard Deviation 18.4	hours
Time to Reach the Target Range	Intensive Insulin Therapy Algorithm	11.8	Standard Deviation 9.4	hours
Frequency of Hypoglycemia	Conventional Insulin Group	4		participants
Frequency of Hypoglycemia	Intensive Insulin Therapy Algorithm	13		participants
Frequency of Severe Hypoglycaemia	Conventional Insulin Group	0	0	participants
Frequency of Severe Hypoglycaemia	Intensive Insulin Therapy Algorithm	1	0	participants
Frequency of Hypokalaemia	Conventional Insulin Group	15		participants
Frequency of Hypokalaemia	Intensive Insulin Therapy Algorithm	15		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Conventional Insulin Group	63
Overall Study	STARTED	Intensive Insulin Therapy Algorithm	67
Overall Study	COMPLETED	Conventional Insulin Group	63
Overall Study	COMPLETED	Intensive Insulin Therapy Algorithm	67
Overall Study	NOT COMPLETED	Conventional Insulin Group	0
Overall Study	NOT COMPLETED	Intensive Insulin Therapy Algorithm	0

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypokalemia	Metabolism and nutrition disorders	Conventional Insulin Group	15	63	15
other	Hypokalemia	Metabolism and nutrition disorders	Intensive Insulin Therapy Algorithm	15	67	15
other	Hypoglycemia	Metabolism and nutrition disorders	Conventional Insulin Group	3	63	4
other	Hypoglycemia	Metabolism and nutrition disorders	Intensive Insulin Therapy Algorithm	11	67	14

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Conventional Insulin Group
Total, all-cause mortality	Intensive Insulin Therapy Algorithm
Total, other adverse events	Conventional Insulin Group	18	63
Total, other adverse events	Intensive Insulin Therapy Algorithm	26	67
Total, serious adverse events	Conventional Insulin Group	0	63
Total, serious adverse events	Intensive Insulin Therapy Algorithm	0	67

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Conventional Insulin Group vs Intensive Insulin Therapy Algorithm: Frequency of Hypoglycemia	Trial comparisons
Conventional Insulin Group vs Intensive Insulin Therapy Algorithm: Frequency of Hypokalaemia	Trial comparisons
Conventional Insulin Group vs Intensive Insulin Therapy Algorithm: Frequency of Severe Hypoglycaemia	Trial comparisons
Conventional Insulin Group vs Intensive Insulin Therapy Algorithm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00353431

GET https://conductscience.org/api/trials/v1/NCT00353431/registered

API reference For AI assistants