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Completed

NCT Number: NCT02105103

European, Open-label, Prospective, Multinational, Multicenter Study in Adult Subjects With Type 1 or Type 2 Diabetes Previously on MDI or CSII Therapy. Subjects Home Setting is Considered Routine Practice.

Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.

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Key information

Conditions

Type 2 Diabetes, Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 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

Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female at least 18 years old
  • Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
  • Intensive insulin therapy by MDI or CSII at least 6 months
  • Willing to self monitor blood glucose 4 times daily

Exclusion criteria

  • Significantly impaired awareness of hypoglycemia
  • Unstable chronic disease other than diabetes
  • Acute illness or inability to recognize pump signals or alarms as determined by the investigator
  • Pregnancy

Treatment and study plan

Accu-Chek® Insight Insulin Pump

Device

A new insulin pump, the Accu-Chek® Insight insulin pump, will be used by all subjects enrolled in this study. The usability of the Accu-Chek® Insight insulin pump for the intended use has already been investigated in a Human Factor study. The study subjects may encounter the following potential risks of CSII therapy while participating in the study: Possible hypoglycemia; Possible hyperglycemia which might progress to ketosis and DKA; Infusion site reactions (bleeding, bruising, discomfort, pruritus, pain, plaster reactions, inflammation, infection etc.)

Primary outcomes

  1. The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).

    Time frame: 6 months

Secondary outcomes

  1. Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures

    Time frame: 6 months

  2. Evaluate subject satisfaction based on surveys of important factors of health-related quality of life

    Time frame: 6 months

  3. Evaluate change in HbA1c from screening to month 3 and 6

    Time frame: 3 weeks screening plus 6 months treatment period

  4. Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)

    Time frame: 6 months

  5. Evaluate change in CGM-derived parameters from month 3 to month 6

    Time frame: 6 months

  6. Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2014
Registry last updated
Sep 9, 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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