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Completed

NCT Number: NCT06466967

Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)

Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Therefore, the key to prevent and/or reduce the development of these chronic complications lies in an adequate and strict glycemic control.

This study consist of a prospective analytical clinical study in patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop (AHCL) treated adult T1D patients previously treated with multiple dose insulin injection (MDI) or other AHCL systems without tighter glucose objective function.

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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–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

About this study

Diabetes is a chronic disease with a relevant public health burden. T1D is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells, which requires the administration of exogenous insulin for its treatment. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life, as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control. Therefore, the key to prevent and/or reduce the development of these complications lies in adequate and strict glycemic control.

On the one hand, the use of advanced hybrid closed-loop (AHCL) systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies. Since 2021, AHCL systems are considered the standard of care, ahead of traditional MDI. On the other hand, among the adjustment parameters of these systems, each AHCL offers different target levels of glycemic control. There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR, improvement in the other glycometric variables, as well as the development of acute or chronic complications. In this regard, a new AHCL system has recently been introduced in Spain: CamAPS FX. It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mg/dL limit. This system allows glycemic objective as low as 80 mg/dL.

However, there is no information on the benefits and safety of using tighter control targets. The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature.

This is monocenter prospective analytical clinical study (non-randomized). The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type 1 diabetes.
  • Age greater than or equal to 18 years.
  • HbA1c > 7% (previous poor glycemic control condition).
  • Prior treatment with MDI or aHCL.

Exclusion criteria

  • Other types of diabetes.
  • Pregnancy or pre-conception control.
  • Uncontrolled psychiatric disease.
  • Current or previous treatment with CamAPS-Ypsopump.
  • No glucometric data available during the periods under study.
  • History of severe hypoglycemia.

Treatment and study plan

Advanced hybrid closed-loop CamAPS FX

Device

Treatment with a strict programmed glucose target (80-99 mg/dL).

Other names: Ypsopump, CamAPS FX

Primary outcomes

  1. Time in Range (TIR) differences

    Time frame: 3 months

    Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets.

Secondary outcomes

  1. Time in Range (TIR) differencies among therapies

    Time frame: 3 months

    Percentage differences in time in range (TIR 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets depending on previous therapy: multi-dose insulin or other AHCL systems with less stringent objectives.

  2. Differences between stringent glucose control targets

    Time frame: 3 months

    To analyze the possible differences on time in range (TIR) using different interstitial glucose targets (from 80 to 99 mg/dL).

  3. HbA1c differences

    Time frame: 3 months

    Differences in HbA1c values after switching to AHCL with tighter glycemic control targets.

  4. Usage of AHCL system

    Time frame: 3 months

    To assess the effect on the time spent using AHCL systems after switching: percentage of time spent using the AHCL system.

  5. MCG adherence

    Time frame: 3 months

    To assess the effect on the time of use of MCG after switching: percentage of MCG sensor activity time.

  6. Total daily insulin requirements

    Time frame: 3 months

    To assess the effect on total daily insulin requirements after switching to AHCL therapy with tighter glycemic objective.

  7. Basal daily insulin requirements

    Time frame: 3 months

    To assess the effect on basal insulin requirements after switching to AHCL therapy with tighter glycemic objective.

  8. Bolus daily insulin requirements

    Time frame: 3 months

    To assess the effect on insulin bolus requirements after switching to AHCL therapy with tighter glycemic objective.

  9. Time in Tight Range (TTIR 70-140 mg/dL) differences

    Time frame: 3 months

    Percentage differences in time in tight range (TIR 70-140 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.

  10. Time Above Range 1 (TAR-1 >180 mg/dL) differences

    Time frame: 3 months

    Percentage differences in Time Above Range 1 (TAR-1 >180 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.

  11. Time Above Range 2 (TAR-2 >250 mg/dL) differences

    Time frame: 3 months

    Percentage differences in Time Above Range 2 (TAR-2 >250 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.

  12. Time Below Range 1 (TBR-1 <70 mg/dL) differences

    Time frame: 3 months

    Time and percentage differences in Time Below Range 1 (TBR-1 <70 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.

  13. Time Below Range 2 (TBR-2 <54 mg/dL) differences

    Time frame: 3 months

    Time and percentage differences in Time Below Range 2 (TBR-2 <54 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.

  14. Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL).

    Time frame: 3 months

    Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL) after switching to aHCL with stringent glycemic control targets.

  15. Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL).

    Time frame: 3 months

    Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL) after switching to AHCL with stringent glycemic control targets.

  16. Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL).

    Time frame: 3 months

    Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL) after switching to AHCL with stringent glycemic control targets.

  17. Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL).

    Time frame: 3 months

    Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL) after switching to AHCL with stringent glycemic control targets.

  18. Nocturnal episodes of hypoglycemia

    Time frame: 3 months

    Nocturnal episodes of hypoglycemia (nº of episodes <70 and <54 mg/dL) after switching to AHCL with stringent glycemic control targets.

  19. Glycemic variability

    Time frame: 3 months

    Glycemic variability (measured throught percentage of the coefficient of variation, CV) differences after switching to AHCL with stringent glycemic control targets.

  20. Mean interstitial glucose

    Time frame: 3 months

    Mean interstitial glucose differences after switching to AHCL with stringent glycemic control targets.

  21. Glucose management indicator (GMI)

    Time frame: 3 months

    Glucose management indicator (GMI) differences after switching to AHCL with stringent glycemic control targets.

  22. Acute complications and mortality

    Time frame: 3 months

    Analyzing the impact of the switch on the frequency of acute complications and mortality due to T1D: severe hypoglycemia, non-acidotic ketotic hyperglycemia, diabetic ketoacidosis, hospital admissions and deaths.

  23. Differences in the Percetage of patients fullfilling the International Consensus of Time in Range

    Time frame: 3 months

    Differences in the Percetage of patients fullfilling the International Consensus of Time in Range (TAR2 <5%, TAR1 <25%, TIR >70%, TBR1 <4%, TBR2 <1%, CV>36%).

Other outcomes

  1. Hypoglycemia Fear Survey (HFS questionnaire)

    Time frame: 3 months

    Assessing the fear of hypoglycemia according to the HFS questionnaire (with values between 24 points and a maximum of 120 indicating a high fear of hypoglycemia) after switching to AHCL with stringent glycemic control targets.

  2. Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: 3 months

    Assessing the satisfaction with treatment according to the DTSQ questionnaire (options graduated from 0 to 6 from the lowest to the highest degree of satisfaction, with a minimum of 0 and a maximum of 12) after switching to AHCL with stringent glycemic control targets.

  3. Clarke's questionnaire

    Time frame: 3 months

    Assessing the awareness of hypoglycemia according to Clarke's questionnaire (indicates high risk of inadvertent hypoglycemia with a score equal to or greater than four) afterswitching to AHCL with stringent glycemic control targets.

  4. Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL)

    Time frame: 3 months

    Assessing the perceived quality of life according to the EsDQOL questionnaire (with values between 46 and a maximum of 230 which would indicate poor satisfaction with current treatment) after switching to AHCL with stringent glycemic control targets.

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Registry information

Official study title

Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control

Acronym: TightT1AHCL

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Mar 19, 2026

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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