Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators

Diabetes Mellitus Type 1 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050868
• Other study ID #: RD000811
• Status: Completed
• Phase: N/A
• First received: January 15, 2010
• Last updated: March 1, 2016
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Tübingen, Baden-Württemberg
• Study type: Interventional

Clinical Trial Summary

This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects >/= 18 years at screening

• Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit

• Subjects have to use a fast acting analog insulin

• HbA1c = 9% (measured with DCA 2000)

• Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (~10 tests per day) with skipped meals and testmeals

• Willing to use the 3 different bolus calculators during the course of the study

• Willing to undergo planned hyperglycemia

• Willing to perform high frequency BG monitoring (> 20 / day) during the experiment

Exclusion Criteria:

• Type 2 Diabetes

• Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)

• Current addiction to alcohol or substances of abuse

• Pregnant or lactating women

• Any known life-threatening disease

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Device:
• Accu-Chek Combo Kit mg DE/de

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL.		6 hours after meal	No
Secondary	To compare the absolute difference between the SMBG value and the target value between the calculators		6 hours after meal	No
Secondary	To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators		6 hours after meal	No
Secondary	To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators		6 hours after meal	No