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Advanced Carbohydrate Counting and Automated Bolus Calculation

NCT ID: NCT02084498

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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The investigators hypothesize, that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates, and that the metabolic control can be further improved with concurrent use of Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACC

Training in advanced carbohydrate counting

Group Type ACTIVE_COMPARATOR

Advanced Carbohydrate Counting

Intervention Type BEHAVIORAL

Training in advanced carbohydrate counting.

ACC + ABC

Training in advanced carbohydrate counting plus the use of an automated bolus calculator.

Group Type EXPERIMENTAL

Automated bolus calculator

Intervention Type DEVICE

Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.

Advanced Carbohydrate Counting

Intervention Type BEHAVIORAL

Training in advanced carbohydrate counting.

Interventions

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Automated bolus calculator

Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.

Intervention Type DEVICE

Advanced Carbohydrate Counting

Training in advanced carbohydrate counting.

Intervention Type BEHAVIORAL

Other Intervention Names

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Accu-Chek Aviva Expert, Roche Diagnostics

Eligibility Criteria

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Inclusion Criteria

* Patients with type 1 diabetes
* Age \>18 years
* Diabetes duration more than 12 months
* Multiple Daily Injections therapy (fast acting analog for meals; long acting analog as basal)
* HbA1c between 8.0% and 11.3%

Exclusion Criteria

* Present or former practice of carbohydrate counting
* Gastroparesis
* Pregnancy or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Eva Hommel

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva E Hommel, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

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Steno Diabetes Center

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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Schmidt S, Meldgaard M, Serifovski N, Storm C, Christensen TM, Gade-Rasmussen B, Norgaard K. Use of an automated bolus calculator in MDI-treated type 1 diabetes: the BolusCal Study, a randomized controlled pilot study. Diabetes Care. 2012 May;35(5):984-90. doi: 10.2337/dc11-2044. Epub 2012 Feb 16.

Reference Type BACKGROUND
PMID: 22344610 (View on PubMed)

Hommel E, Schmidt S, Vistisen D, Neergaard K, Gribhild M, Almdal T, Norgaard K. Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial. Diabet Med. 2017 May;34(5):708-715. doi: 10.1111/dme.13275. Epub 2016 Nov 10.

Reference Type DERIVED
PMID: 27761942 (View on PubMed)

Other Identifiers

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StenoABC

Identifier Type: -

Identifier Source: org_study_id