Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients

NCT04847778 | Completed

• 1 other identifier: INSULCLOCK2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

Insulclock® is a small electronic device developed to facilitate the optimal administration of insulin. This device works as an add-on module of commercially available insulin pens and monitors the date, time and dose of injections, the type of insulin injected, the duration of injections and insulin temperature. The Insulclock 360 app allows automatic data logging, report generation and reminder setting, among other functions. In this study, we pretend to show the clinical impact of Insulclock system, both device and mobile application, on glycemic indices, treatment compliance, and quality of life in patients with persistent poorly controlled T1DM. Material and methods: Randomized open-label multicenter controlled trial to evaluate glycemic control, the number of missed and delayed insulin doses, and quality of life after seven weeks of Insulclock 360 use in participants with uncontrolled DM1. We will also compare these results between patients with or without receiving system reminders and alerts. This study aims to assess the effect of Insulclock on glycemic control, treatment adherence, and quality of life. As a secondary objective, we will compare the study outcomes between participants in the Active and Masked Insulclock groups (i.e., with or without receiving alerts and reminders and accessing the app). To assess glycemic control, we will measure HbA1C and glycemic indices. Glycemic variability indices will be monitored with the FreeStyle Libre™ and included glucose coefficient of variation (CV), standard deviation (SD), time in range (TIR), time above range (TAR), and time below range (TBR). Mean glucose levels will be obtained from 48-h time intervals with the FreeStyle Libre. A late meal bolus (mistimed) will be considered when Insulclock detects the injection at least 30 minutes after the CGM rise. To identify meal glucose excursions, we will use the Glucose Rate Increase Detector (GRID) algorithm, which estimates the rate of change (ROC) of glucose from CGM data. Participants will complete the ITSQ and the DTSQ, which are validated questionnaires to assess the diabetes treatment satisfaction.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes Mellitus; Insulin Pen; Glycosylated Hemoglobin; Time in Range; Adherence; Continuous Glucose Monitoring; Insulclock; Basal glycaemia; Preprandial glycaemia; Endocrine System Diseases; Insulin-dependent; Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

• Change in "Time In Range" (TIR)

  TIR, is the percentage of time that a person spends with their blood glucose levels in a target range. The range will vary depending on the person, but general guidelines suggest starting with a range of 70 to 180 mg/dl. Glucose levels are obtained from Continuous Glucose Monitor (CGM) and investigators compare the results obtained within the first 4 weeks of the study with the values of the next 3 weeks of the study.

  Baseline, 7 weeks

• Number of daily insulin injections irregularities

  The number of insulin injections irregularities (omission, mistiming and dosing) will be registered in the Insulclock pen cap device and will be transferred to the Insulclock mobile application in real time to monitor treatment adherence.The moment of the insulin injection will be compared with the moment of food intake analyzing the glycemic excursion. Investigators will determine if the insulin was injected with ahead of time enough, so that catalog the injection as on time, mistiming or omission.

  Week 0 through week 7

Secondary Outcomes (3)

• Change in Mean glucose

  Baseline, 7 weeks

• Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.

  Baseline, 7 weeks

• Change in Insulin Treatment Satisfaction Questionnaire (ITSQ-change) Score.

  Baseline, 7 weeks

Study Arms (2)

Masked arm

ACTIVE COMPARATOR

* Participants will be instructed on the correct installation and use of the Insulclock device and app on masked mode for recording insulin bolus information. * Participants do not receive any other information and will not have access to the Insulclock 360 application from the Internet. * Participants will keep administering insulin treatment as usual.

Device: Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.

Active arm

ACTIVE COMPARATOR

* Participants will receive detailed instructions on using the Insuclock 360 app and Insulclock device * Participants will be instructed and motivated for full use of all system functions: alarms, messages to the caregivers and investigation team.

Device: Use of Insulclock system, both Insulclock device and Insulclock 360 app.; Device: Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.

Interventions

Use of Insulclock system, both Insulclock device and Insulclock 360 app. DEVICE

Visit 5, during week 4. Randomization will be applied: Active group will use all functionalities of Insulclock 360. They will have reminders, all their information and statistics at the disposition of the patient and healthcare providers, they have the assistance if desired of an ally or caregiver, a bolus calculator and the rest of functionalities described in the protocol.

Active arm

Use of Insulclock system, both Insulclock device and Insulclock app on masked mode. DEVICE

Visit 5, during week 4. Randomization will be applied: Masked group will remain with the masked system, without functionalities.

Active arm; Masked arm

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age range: 14 to 80 years
• DM1 diagnosed
• Patients with type 1 diabetes and poor glycemic control, defined as:
• HbA1c ≥ 6.5% during more than a year
• and/or extreme variations (more than 1% of change in HbA1c in the last 2 years)
• and regular visits to the Endocrinology Unit / Diabetes Unit (more than four each year).
• Signed informed consent form
• Ability of the subjects to use the system and fill the included questionnaires
• Ability and willingness of following and be compatible with the protocol of the clinical trial

You may not qualify if:

• Rejection or inability to give the informed consent to participate in the trial.
• Pregnancy or lactation
• Addiction or abuse of alcohol, or history of drug abuse in the last years
• Dementia diagnosis
• Acute infection
• Any illness or condition that, according to investigator, could interfere with the trial

Sponsors & Collaborators

• Hospital General de Segovia: lead
• Insulcloud S.L.: collaborator

Study Sites (4)

Endocrinology and Nutrition Unit, Arquitecto Marcide Hospital

Ferrol, A Coruña, 15405, Spain

Location

Endocrinology and Nutrition Service, Hospital de Cruces.

Bilbao, 48903, Spain

Location

Endocrinology and Nutrition Service, Hospital Central de Asturias

Oviedo, 33011, Spain

Location

Endocrinology and Nutrition Unit /Diabetes Unit, Hospital General de Segovia

Segovia, 40002, Spain

Location

Related Publications (18)

• Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11.

  PMID: 21987347 BACKGROUND

• American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.

  PMID: 26696682 BACKGROUND

• Borschuk AP, Everhart RS. Health disparities among youth with type 1 diabetes: A systematic review of the current literature. Fam Syst Health. 2015 Sep;33(3):297-313. doi: 10.1037/fsh0000134. Epub 2015 May 18.

  PMID: 25984737 BACKGROUND

• Martyn-Nemeth P, Schwarz Farabi S, Mihailescu D, Nemeth J, Quinn L. Fear of hypoglycemia in adults with type 1 diabetes: impact of therapeutic advances and strategies for prevention - a review. J Diabetes Complications. 2016 Jan-Feb;30(1):167-77. doi: 10.1016/j.jdiacomp.2015.09.003. Epub 2015 Sep 7.

  PMID: 26439754 BACKGROUND

• Stolpe S, Kroes MA, Webb N, Wisniewski T. A Systematic Review of Insulin Adherence Measures in Patients with Diabetes. J Manag Care Spec Pharm. 2016 Nov;22(11):1224-1246. doi: 10.18553/jmcp.2016.22.11.1224.

  PMID: 27783551 BACKGROUND

• Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care. 2010 Feb;33(2):240-5. doi: 10.2337/dc09-1348.

  PMID: 20103556 BACKGROUND

• Celik S, Cosansu G, Erdogan S, Kahraman A, Isik S, Bayrak G, Bektas B, Olgun N. Using mobile phone text messages to improve insulin injection technique and glycaemic control in patients with diabetes mellitus: a multi-centre study in Turkey. J Clin Nurs. 2015 Jun;24(11-12):1525-33. doi: 10.1111/jocn.12731. Epub 2014 Nov 25.

  PMID: 25422134 BACKGROUND

• Arsand E, Muzny M, Bradway M, Muzik J, Hartvigsen G. Performance of the first combined smartwatch and smartphone diabetes diary application study. J Diabetes Sci Technol. 2015 May;9(3):556-63. doi: 10.1177/1932296814567708. Epub 2015 Jan 14.

  PMID: 25591859 BACKGROUND

• Klausmann G, Hramiak I, Qvist M, Mikkelsen KH, Guo X. Evaluation of preference for a novel durable insulin pen with memory function among patients with diabetes and health care professionals. Patient Prefer Adherence. 2013 Apr 5;7:285-92. doi: 10.2147/PPA.S41929. Print 2013.

  PMID: 23630416 BACKGROUND

• Guo X, Sommavilla B, Vanterpool G, Qvist M, Bethien M, Lilleore SK. Evaluation of a new durable insulin pen with memory function among people with diabetes and healthcare professionals. Expert Opin Drug Deliv. 2012 Apr;9(4):355-6. doi: 10.1517/17425247.2012.671808.

  PMID: 22432521 BACKGROUND

• Danne T, Forst T, Deinhard J, Rose L, Moennig E, Haupt A. No effect of insulin pen with memory function on glycemic control in a patient cohort with poorly controlled type 1 diabetes: a randomized open-label study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1392-7. doi: 10.1177/193229681200600619.

  PMID: 23294785 BACKGROUND

• Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.

  PMID: 14993580 BACKGROUND

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

• Phan TL, Hossain J, Lawless S, Werk LN. Quarterly visits with glycated hemoglobin monitoring: the sweet spot for glycemic control in youth with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):341-5. doi: 10.2337/dc13-0980. Epub 2013 Sep 23.

  PMID: 24062334 BACKGROUND

• Luo M, Tan KHX, Tan CS, Lim WY, Tai ES, Venkataraman K. Longitudinal trends in HbA1c patterns and association with outcomes: A systematic review. Diabetes Metab Res Rev. 2018 Sep;34(6):e3015. doi: 10.1002/dmrr.3015. Epub 2018 May 22.

  PMID: 29663623 BACKGROUND

• Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, Ruiz L. Insulclock: A Novel Insulin Delivery Optimization and Tracking System. Diabetes Technol Ther. 2019 Apr;21(4):209-214. doi: 10.1089/dia.2018.0361. Epub 2019 Mar 21.

  PMID: 30896261 BACKGROUND

• Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, Cruz-Bravo M, Maria-Sanchez C, Poza G, Ruiz-Valdepenas L. Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial. Diabetes Technol Ther. 2020 Sep;22(9):686-690. doi: 10.1089/dia.2019.0427. Epub 2020 Mar 5.

  PMID: 32069067 BACKGROUND

• Ruiz-Ramos M, Escolar-Pujolar A, Mayoral-Sanchez E, Corral-San Laureano F, Fernandez-Fernandez I. [Diabetes mellitus in Spain: death rates, prevalence, impact, costs and inequalities]. Gac Sanit. 2006 Mar;20 Suppl 1:15-24. doi: 10.1157/13086022. Spanish.

  PMID: 16539961 BACKGROUND

Related Links

• Homepage of the Insuclock device and Insulclock 360 app

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Endocrine System Diseases; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fernando Gomez Peralta, Physician

  Hospital General de Segovia, Segovia, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: * Patients will be instructed on the correct installation and use of the Insulclock 360 system for recording insulin bolus information. * Patients do not receive any other information and will not have access to the Insulclock 360 application from the Internet. * They will keep administering insulin treatment as before. * Randomization is blind to the recruiting investigator.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will start the study using Insulclock, device and app on Masked Mode. At the week 4 patients will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Patients randomized in the Insulclock Active Group will receive detailed instructions on using the Insulclock device and Insulclock 360 mobile application and will be instructed and motivated for full use of all system functions (alarms, messages to the caregivers and investigation team). Patients randomized in the Insulclock Masked Group will be instructed on the correct installation and use of the Insulclock system for recording insulin bolus information but they will not receive any other information and will not have access to the Insulclock 360 application from the Internet and will keep administering insulin treatment as before. A healthcare professional will apply a FreeStyle Libre sensor to the upper arm in all the participants who do not use a CGM.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 19, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)