Study of the Effects of Carbohydrate Counting

NCT ID: NCT01223547

Last Updated: 2014-01-28

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

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 an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.

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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Control group

Participants in this arm continues their usual insulin therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Carb counting

Participants in this arm are taught carb counting

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Participants are taught the principles of carb counting

Carb counting and bolus calculator

Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.

Interventions

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Education

Participants are taught the principles of carb counting

Intervention Type OTHER

Education

Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.

Intervention Type OTHER

Other Intervention Names

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The integrated glucose meter and bolus calculator: Aviva Expert, Roche

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* Diabetes duration at least 12 months
* MDI therapy
* HbA1c 8-10,5% (both included)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Danish Council for Strategic Research

OTHER

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Signe Schmidt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Signe Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , 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 DERIVED
PMID: 22344610 (View on PubMed)

Other Identifiers

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BOLUSCAL

Identifier Type: -

Identifier Source: org_study_id

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