Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL

NCT05109520 | Completed

• 1 other identifier: S65399
• Study Type: observational
• Target: 867
• Locations: 1 country
• Sites: 3

Brief Summary

Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life. Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational). Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group). The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.

Conditions

Type 1 Diabetes

Keywords

Insulin Glargine 300 U/mL; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Time in range (TIR, 70-180 mg/dL)

  The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300

  maximum 24 months

Secondary Outcomes (10)

• HbA1c

  maximum 24 months

• Time in range (TIR, 70-180 mg/dL)

  maximum 24 months

• Hypoglycemia

  maximum 24 months

• Hyperglycemia

  maximum 24 months

• Mean glycemia

  maximum 24 months

Other Outcomes (5)

• Insulin dose

  maximum 24 months

• Body mass index

  maximum 24 months

• Severe hypoglycemia rate

  maximum 24 months

Study Arms (2)

investigational group

Participants of the FUTURE study who switched during the study to Gla-300

Drug: Insulin Glargine 300 UNT/ML [Toujeo]

control group

Participants of the FUTURE study who did not switch to Insulin Gla-300

Interventions

Insulin Glargine 300 UNT/ML [Toujeo] DRUG

Switch during standard routine care to Gla-300.

investigational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with type 1 diabetes who participated in the FUTURE study.

You may qualify if:

• participant in the FUTURE study
• diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
• use of insulin pens for the entirety of the FUTURE study
• used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®)
• switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months)

You may not qualify if:

• use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300
• not using bolus insulin (only basal insulin)
• for women: pregnant or planning pregnancy during the FUTURE study
• Control group
• participant in the FUTURE study for at least 18 months
• diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
• use of insulin pens for the entirety of the FUTURE study
• use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study
• use of Fast-acting insulin aspart (Fiasp®)
• not using bolus insulin (only basal insulin)
• for women: pregnant or planning pregnancy during the FUTURE study
• switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 \[Toujeo®\] or Insulin Degludec \[Tresiba®\] will be used for this control participant)

Sponsors & Collaborators

• prof dr Pieter Gillard: lead
• University Hospital, Antwerp: collaborator
• Onze Lieve Vrouw Hospital: collaborator

Study Sites (3)

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Charleer S, Fieuws S, De Block C, Bolsens N, Nobels F, Mikkelsen K, Mathieu C, Gillard P. Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study. Diabetes Technol Ther. 2024 Jul;26(7):488-493. doi: 10.1089/dia.2023.0371. Epub 2024 Mar 6.

  PMID: 38386438 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pieter Gillard, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigators

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 5, 2021
• Study Start: September 8, 2021
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

BE (3)