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

NCT06466967 | Completed FDA Device

• 1 other identifier: CI-712
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; advanced hybrid closed-loop; tight time in range; artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Time in Range (TIR) differences

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

  3 months

Secondary Outcomes (23)

• Time in Range (TIR) differencies among therapies

  3 months

• Differences between stringent glucose control targets

  3 months

• HbA1c differences

  3 months

• Usage of AHCL system

  3 months

• MCG adherence

  3 months

Other Outcomes (4)

• Hypoglycemia Fear Survey (HFS questionnaire)

  3 months

• Diabetes Treatment Satisfaction Questionnaire (DTSQ)

  3 months

• Clarke's questionnaire

  3 months

Study Arms (1)

Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump)

Patients with type 1 diabetes on treatment with AHCL (CamAPS-Ypsopump) and a strict programmed glucose target (80-99 mg/dL).

Device: Advanced hybrid closed-loop CamAPS FX

Interventions

Advanced hybrid closed-loop CamAPS FX DEVICE

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

Also known as: Ypsopump, CamAPS FX

Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 1 diabetes and poor prior glycemic control, regardless previous treatment, attended in the Public Health System of Castilla-La Mancha in the Health Area of the Ciudad Real General University Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Sites (1)

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

Location

Related Publications (6)

• Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.

  PMID: 31177185 BACKGROUND

• Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, Tauschmann M, Allen JM, Wilinska ME, Pieber TR, Evans ML, Hovorka R. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):261-270. doi: 10.1016/S2213-8587(17)30001-3. Epub 2017 Jan 14.

  PMID: 28094136 BACKGROUND

• Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.

  PMID: 31618560 BACKGROUND

• Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.

  PMID: 33453783 BACKGROUND

• Beato-Vibora PI, Chico A, Moreno-Fernandez J, Bellido-Castaneda V, Nattero-Chavez L, Picon-Cesar MJ, Martinez-Brocca MA, Gimenez-Alvarez M, Aguilera-Hurtado E, Climent-Biescas E, Azriel-Mir S, Rebollo-Roman A, Yoldi-Vergara C, Pazos-Couselo M, Alonso-Carril N, Quiros C. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care. 2024 Feb 1;47(2):216-224. doi: 10.2337/dc23-1355.

  PMID: 37948469 BACKGROUND

• El Malahi A, Van Elsen M, Charleer S, Dirinck E, Ledeganck K, Keymeulen B, Crenier L, Radermecker R, Taes Y, Vercammen C, Nobels F, Mathieu C, Gillard P, De Block C. Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e570-e581. doi: 10.1210/clinem/dgab688.

  PMID: 34534297 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: June 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: March 15, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

ES (1)