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Completed

NCT Number: NCT05434559

Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec

Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.

People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.

Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.

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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

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • People with T1D ≥18 years at the moment of switch to Insulin Degludec
  • Diagnosed with T1D ≥2 years before switch to Insulin Degludec
  • On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec
  • ≥6 months use of Insulin Degludec at moment of datacollection
  • Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec

Exclusion criteria

  • People with T1D <18 years at the moment of switch to Insulin Degludec
  • People without T1D or with T1D <2 years before switch to Insulin Degludec
  • Women with T1D who are pregnant or planning pregnancy during -12 and +12 months
  • Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months
  • Start to use non-insulin antidiabetic agents between -12 and +12 months
  • Having received treatment with oral or injectable corticosteroids during -12 and +12 months
  • Undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months
  • <6 months use of Insulin Degludec at moment of datacollection
  • Not using continuous glucose monitoring or <2 years before switch to Insulin Degludec

Treatment and study plan

insulin degludec

Drug

Switch during standard routine care to Insulin Degludec.

Primary outcomes

  1. Time in range

    Time frame: 12 months

    the change in time in range (TIR: 70-180 mg/dL, averaged per month) over 24 hours between 12 (±2) months before switch to 12 (±2) months after switch to Insulin Degludec

Secondary outcomes

  1. HbA1c

    Time frame: 12 months

    difference in HbA1c between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  2. Time below 54 mg/dL

    Time frame: 12 months

    difference in time in clinically significant hypoglycemia (<54 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  3. Time in range

    Time frame: 12 months

    difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  4. Time below 70 mg/dL

    Time frame: 12 months

    difference in time below range (<70 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  5. Time above 180 mg/dL

    Time frame: 12 months

    difference in time above range (>180 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  6. Time above 250 mg/dL

    Time frame: 12 months

    difference in time in significant hyperglycemia (>250 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  7. Mean glucose

    Time frame: 12 months

    difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  8. Glycemic variability

    Time frame: 12 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 between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  9. Insulin dose

    Time frame: 12 months

    difference in insulin dose (total daily dose, basal dose, bolus dose) between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  10. Body mass index

    Time frame: 12 months

    difference in body mass index (BMI) between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

Other outcomes

  1. Hospital visits and/or admissions due to hypoglycemia or ketoacidosis

    Time frame: 12 months

    difference in number of hospital visits and/or admissions due to hypoglycemia or ketoacidosis between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec

  2. Participants who discontinue the use of Insulin Degludec

    Time frame: 12 months

    number of participants who discontinue the use of Insulin Degludec

  3. Reason for discontinuation of Insulin Degludec

    Time frame: 12 months

    overview of reasons to discontinue Insulin Degludec (in tabular view)

  4. Indication for use of Insulin Degludec

    Time frame: baseline

    overview of reasons to start Insulin Degludec (in tabular view)

  5. Glycemic consensus targets

    Time frame: 12 months

    proportion of people reaching HbA1c and glucose consensustargets 12 [±2] months after switch to Insulin Degludec

Sponsors and collaborators

Lead sponsor

prof dr Pieter Gillard

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study

Acronym: GLADE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Dec 21, 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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