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CompletedNCT01050868Updated Mar 3, 2016

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

An interventional study of Accu-Chek Combo Kit mg DE/de in Diabetes Mellitus Type 1, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-03.

Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus Type 1
03

In context

Diabetes Mellitus, Type 1

3,521 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Single Arm

    Device: Accu-Chek Combo Kit mg DE/de

Interventions

  • DeviceAccu-Chek Combo Kit mg DE/de
06

What researchers measure

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.

    Time frame: 6 hours after meal

Secondary outcomes

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

    Time frame: 6 hours after meal

  2. 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

  3. 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

07

Study locations

1 site
  • Ulm, 89081, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01050868
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 18, 2010
Start date
Jun 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 3, 2016

Study contacts

Bettina Petersen
study director · Roche Diagnostics GmbH / Diabetes Care
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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