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

NCT01050868 | Completed

• 1 other identifier: RD000811
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  6 hours after meal

• 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

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Device: Accu-Chek Combo Kit mg DE/de

Interventions

Accu-Chek Combo Kit mg DE/de DEVICE

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bettina Petersen

  Roche Diagnostics GmbH / Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 3, 2016

Record last verified: 2011-01

Locations

DE (1)