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NCT Number: NCT05109520

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

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.

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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

Observational

Primary location

Onze Lieve Vrouw Ziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

  • Investigational group

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Insulin Glargine 300 UNT/ML [Toujeo]

Drug

Switch during standard routine care to Gla-300.

Primary outcomes

  1. Time in range (TIR, 70-180 mg/dL)

    Time frame: maximum 24 months

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

Secondary outcomes

  1. HbA1c

    Time frame: maximum 24 months

    difference in HbA1c

  2. Time in range (TIR, 70-180 mg/dL)

    Time frame: maximum 24 months

    difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am

  3. Hypoglycemia

    Time frame: maximum 24 months

    difference in time in hypoglycemia (<54 mg/dL, <70 mg/dL, ≥54-<70 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am

  4. Hyperglycemia

    Time frame: maximum 24 months

    difference in time in hyperglycemia (>180 mg/dL, >250 mg/dL, >180-≤250 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am

  5. Mean glycemia

    Time frame: maximum 24 months

    difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am

  6. Glycemic variability

    Time frame: maximum 24 months

    difference in glycemic variability (standard deviation, coefficient of variation; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am

  7. Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire

    Time frame: maximum 24 months

    Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))

  8. Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry

    Time frame: maximum 24 months

    Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))

  9. Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire

    Time frame: maximum 24 months

    Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))

  10. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)

    Time frame: maximum 24 months

    Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))

Other outcomes

  1. Insulin dose

    Time frame: maximum 24 months

    difference in insulin dose (basal, bolus and total)

  2. Body mass index

    Time frame: maximum 24 months

    difference in body mass index (BMI)

  3. Severe hypoglycemia rate

    Time frame: maximum 24 months

    difference in self-reported severe hypoglycemic events

  4. Hypoglycemic coma rate

    Time frame: maximum 24 months

    difference in self-reported hypoglycemic comas

  5. Hospitalization

    Time frame: maximum 24 months

    difference in hospitalizations due to hypoglycemia or ketoacidosis

Sponsors and collaborators

Lead sponsor

prof dr Pieter Gillard

Other

Collaborators

  • Onze Lieve Vrouw Hospital
  • University Hospital, Antwerp

Registry information

Official study title

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: A FUTURE Substudy

Acronym: FUTURE-GLARE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Aug 30, 2022

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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