Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01519466
First received: January 6, 2012
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.

Condition Intervention
Type 1 Diabetes
Device: FreeStyle InsuLinx
Device: FreeStyle Freedom Lite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • Time in Target Blood Glucose Range [ Time Frame: Day 1-15 compared with Day 60-74 ] [ Designated as safety issue: No ]
    Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)


Secondary Outcome Measures:
  • HbA1c [ Time Frame: Day 1 compared with Day 74 ] [ Designated as safety issue: No ]

    HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).

    The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).


  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. [ Time Frame: Day 60 compared to day 1 ] [ Designated as safety issue: No ]

    The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).

    There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).

    The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.



Enrollment: 55
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
Device: FreeStyle InsuLinx
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
Control
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
Device: FreeStyle Freedom Lite
FreeStyle Freedom Lite is a blood glucose meter

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
  • HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
  • Age 18 and over
  • In the investigator's opinion, thought technically capable of using masked CGM
  • Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
  • Willing to perform a minimum of 4 SMBG tests per day during study

Exclusion Criteria:

  • Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
  • Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
  • Subject is pregnant / planning to become pregnant within the planned study timeline
  • Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
  • Subject is currently on an insulin pump
  • Subject is currently using the FreeStyle InsuLinx
  • Subject is currently using the FreeStyle Freedom Lite
  • Subject is currently using CGM
  • Subject has an allergy to medical grade adhesives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519466

Locations
Germany
Diabetes Zentrum Mergentheim
Bad Mergentheim, Germany, 97980
Diabetes-Zentrum für Kinder und Jugendliche
Hannover, Germany, 30173
Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany, D-89081
Netherlands
VU University Medical Centre (VUMC)
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Principal Investigator: Prof. Michaela Diamant VU University Medical Centre (VUMC)
  More Information

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01519466     History of Changes
Other Study ID Numbers: ADC-PMR-INX-11012 
Study First Received: January 6, 2012
Results First Received: November 12, 2015
Last Updated: March 3, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission

Keywords provided by Abbott Diabetes Care:
Diabetes
SMBG
Insulin calculator

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016