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Completed

NCT Number: NCT03671161

Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients

Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

About this study

This is a non-controlled proof of concept prospective pilot study in adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and started a FGM system (Free Style Libre®) during 6 months, hoping this intervention can reengage patients in self-management, reduce HbA1c without increasing the risk of ketoacidocetosis (DKA) and severe hypoglycemia (SH), and keep the DTSQ (Diabetes Treatment Satisfaction Questionnaire) and HFS (Hypoglycemia Fear Scale) at good levels.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults with type 1 diabetes, aged between 18 and 55, HbA1c >9% (75 mmol/mol), multi daily insulin injections (MDI) treatment, maximum 2 SMBG /day

Exclusion criteria

  • diabetes with less than 1 year duration, severe active retinopathy requiring laser therapy, severe psychiatric illness, pregnancy, inability to communicate in French, concomitant severe active disease, patients already using a FGM or a CGM

Treatment and study plan

Insulin Pump and flash glucose monitoring

Device

Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.

Primary outcomes

  1. Change in HbA1c ≥1%

    Time frame: 6 months

    Blood samples at baseline and 6 months

  2. Number of severe hypoglycemia episodes

    Time frame: 6 months

    Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring

  3. Number of ketoacidosis episodes

    Time frame: 6 months

Secondary outcomes

  1. Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire)

    Time frame: 6 months

    Filling questionnaires at baseline and 6 months. DTSQ (Diabetes treatment questionnaire) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome

  2. Any positive change in HFS scale (Hypoglycemia Fear Scale)

    Time frame: 6 months

    Filling questionnaires at baseline and 6 months. HFS (Hypoglycemia fear scale) assesses participant's fear of hypoglycemia both overall and separately for behavior (10 items) and worry (17 items), both items scoring from 1 to 5, with lower score indicating better outcome

  3. Number of Hypoglycemia episodes

    Time frame: 6 months

    Number of hypoglycemia episodes, evaluated by Flash glucose monitoring

  4. Frequency of hypoglycemia episodes

    Time frame: 6 months

    Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring

  5. Frequency of severe hypoglycemia episodes

    Time frame: 6 months

    Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring

  6. Frequency of ketoacidosis episodes

    Time frame: 6 months

  7. Any changes in Weight

    Time frame: 6 months

    Weight measures at baseline 2 months and 6 months

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements

Acronym: FREESTYLE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 14, 2018
Registry last updated
May 20, 2020

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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