NCT02084498

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

February 24, 2014

Last Update Submit

November 20, 2014

Conditions

Type 1 Diabetes

Keywords

Automated bolus calculator (ABC)Advanced carbohydrate counting (ACC)Patient empowerment

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    Baseline, 12 months

Secondary Outcomes (1)

  • Frequency of serious hypoglycemic events

    Baseline, 12 months

Other Outcomes (3)

  • Frequency of glucose below, in or above target 4-8 mmol/l assessed by blinded Continuous Glucose Monitoring 6 days before study start and 6 days before ending the study

    Baseline, 12 months

  • Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study

    Baseline, 12 months

  • Treatment Satisfaction

    Baseline, 12 months

Study Arms (2)

ACC

ACTIVE COMPARATOR

Training in advanced carbohydrate counting

Behavioral: Advanced Carbohydrate Counting

ACC + ABC

EXPERIMENTAL

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

Device: Automated bolus calculatorBehavioral: Advanced Carbohydrate Counting

Interventions

Automated bolus calculatorDEVICE

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

Also known as: Accu-Chek Aviva Expert, Roche Diagnostics
ACC + ABC
Advanced Carbohydrate CountingBEHAVIORAL

Training in advanced carbohydrate counting.

ACCACC + ABC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Present or former practice of carbohydrate counting
  • Gastroparesis
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 22344610BACKGROUND

  • 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.

    PMID: 27761942DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Patient Participation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Eva E Hommel, MD, DMSc

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 12, 2014

Study Start

September 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

DK(1)