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

Primary Purpose

Diabetes Mellitus Type 1

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Accu-Chek Combo Kit mg DE/de

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To compare the absolute difference between the SMBG value and the target value between the calculators

To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators

To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators

Full Information

NCT ID

NCT01050868

First Posted

January 15, 2010

Last Updated

March 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01050868

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 1

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Accu-Chek Combo Kit mg DE/de

Primary Outcome Measure Information:

Title

Time Frame

6 hours after meal

Secondary Outcome Measure Information:

Title

To compare the absolute difference between the SMBG value and the target value between the calculators

Time Frame

6 hours after meal

Title

To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators

Time Frame

6 hours after meal

Title

To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators

Time Frame

6 hours after meal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bettina Petersen

Organizational Affiliation

Roche Diagnostics GmbH / Diabetes Care

Official's Role

Study Director

Facility Information:

City

Ulm

ZIP/Postal Code

89081

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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