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

NCT03671161 | Completed

• 1 other identifier: CIC1421-18-15
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus); Diabetes Mellitus, Type 1

Keywords

Diabetes Type 1; Insulin Pump; flash glucose monitoring; hypoglycemia; ketoacidocetosis; DTSQ; HFS

Outcome Measures

Primary Outcomes (3)

• Change in HbA1c ≥1%

  Blood samples at baseline and 6 months

  6 months

• Number of severe hypoglycemia episodes

  Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring

  6 months

• Number of ketoacidosis episodes

  6 months

Secondary Outcomes (7)

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

  6 months

• Any positive change in HFS scale (Hypoglycemia Fear Scale)

  6 months

• Number of Hypoglycemia episodes

  6 months

• Frequency of hypoglycemia episodes

  6 months

• Frequency of severe hypoglycemia episodes

  6 months

Study Arms (1)

Patients with poorly controlled diabetes type 1

EXPERIMENTAL

Adults with type 1 diabetes, HbA1c \>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day swithced to Insulin Pump and flash glucose monitoring

Device: Insulin Pump and flash glucose monitoring

Interventions

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.

Patients with poorly controlled diabetes type 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• Halbron M, Bourron O, Andreelli F, Ciangura C, Jacqueminet S, Popelier M, Bosquet F, Rouanet S, Amouyal C, Hartemann A. Insulin Pump Combined with Flash Glucose Monitoring: A Therapeutic Option to Improve Glycemic Control in Severely Nonadherent Patients with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jul;21(7):409-412. doi: 10.1089/dia.2019.0041.

  PMID: 31265349 RESULT

MeSH Terms

Conditions

Glucose Metabolism Disorders; Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant director, clinical investigation center Paris Est

Model Details: 19 patients with type 1 diabetes, HbA1c \>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

FR (1)