Efficacy of Automated Bolus Calculation in Type 2 Diabetes

NCT ID: NCT02887898

Last Updated: 2020-01-22

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-11-30

Brief Summary

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The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.

Detailed Description

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Conditions

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Type 2 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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Carb counting and bolus calculator

Education in carb counting and the use of an automated bolus calculator

Group Type ACTIVE_COMPARATOR

Automated bolus calculator

Intervention Type DEVICE

Education

Intervention Type OTHER

Carb counting

Education in carb counting and manual calculation of insulin bolus

Group Type PLACEBO_COMPARATOR

Education

Intervention Type OTHER

Interventions

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Automated bolus calculator

Intervention Type DEVICE

Education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes \> 1 year
* Age 18 years or older
* HbA1C \> 64 mmol/mol (8.0 %)
* Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months
* GAD-antibody negative
* Naïve to bolus calculators

Exclusion Criteria

* Pregnancy or breast feeding
* Gastroparesis
* Severe nephropathy (eGFR\<30 mL/min/1,73 m2)
* Use of sulfonylurea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merete Bechmann Christensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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Christensen MB, Serifovski N, Herz AMH, Schmidt S, Hommel E, Raimond L, Perrild H, Gotfredsen A, Gaede P, Norgaard K. Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A Randomized Clinical Trial. Diabetes Technol Ther. 2021 Feb;23(2):95-103. doi: 10.1089/dia.2020.0276. Epub 2020 Sep 21.

Reference Type DERIVED
PMID: 32846108 (View on PubMed)

Other Identifiers

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BolusCal2

Identifier Type: -

Identifier Source: org_study_id

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