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Advanced Carbohydrate Counting and Automated Bolus Calculation

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Automated bolus calculator
Advanced Carbohydrate Counting
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Automated bolus calculator (ABC), Advanced carbohydrate counting (ACC), Patient empowerment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steno Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ACC

ACC + ABC

Arm Description

Training in advanced carbohydrate counting

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

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

Frequency of serious hypoglycemic events

Full Information

First Posted
February 24, 2014
Last Updated
November 20, 2014
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02084498
Brief Title
Advanced Carbohydrate Counting and Automated Bolus Calculation
Official Title
A Randomized Controlled Large Study of Flexible Intensified Insulin Therapy (FIIT) With Carbohydrate Counting (CHC) Versus FIIT With Carbohydrate Counting and Automated Bolus Calculation (ABC)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Automated bolus calculator (ABC), Advanced carbohydrate counting (ACC), Patient empowerment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACC
Arm Type
Active Comparator
Arm Description
Training in advanced carbohydrate counting
Arm Title
ACC + ABC
Arm Type
Experimental
Arm Description
Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
Intervention Type
Device
Intervention Name(s)
Automated bolus calculator
Other Intervention Name(s)
Accu-Chek Aviva Expert, Roche Diagnostics
Intervention Description
Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.
Intervention Type
Behavioral
Intervention Name(s)
Advanced Carbohydrate Counting
Intervention Description
Training in advanced carbohydrate counting.
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Frequency of serious hypoglycemic events
Time Frame
Baseline, 12 months
Other Pre-specified Outcome Measures:
Title
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
Time Frame
Baseline, 12 months
Title
Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study
Time Frame
Baseline, 12 months
Title
Treatment Satisfaction
Description
Measured by Diabetes Treatment Satisfaction Questionnaire
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva E Hommel, MD, DMSc
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22344610
Citation
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.
Results Reference
background
PubMed Identifier
27761942
Citation
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.
Results Reference
derived

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Advanced Carbohydrate Counting and Automated Bolus Calculation

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