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Completed

NCT Number: NCT01519466

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreeStyle InsuLinx

Device

FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.

FreeStyle Freedom Lite

Device

FreeStyle Freedom Lite is a blood glucose meter

Primary outcomes

  1. Time in Target Blood Glucose Range

    Time frame: Day 1-15 compared with Day 60-74

    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 outcomes

  1. HbA1c

    Time frame: Day 1 compared with Day 74

    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).

  2. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.

    Time frame: Day 60 compared to day 1

    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.

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2012
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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