Diabetes Mellitus, Type 1Segoclock2NCT04847778
Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients
A study testing Use of Insulclock system, both Insulclock device and Insulclock 360 app. and Use of Insulclock system, both Insulclock device and Insulclock app on masked mode. in people with Diabetes Mellitus, Type 1, run by Hospital General de Segovia at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Use of Insulclock system, both Insulclock device and Insulclock 360 app. and Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Mar 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Endocrinology and Nutrition Service, Hospital de Cruces.
Bilbao, 48903
Endocrinology and Nutrition Unit, Arquitecto Marcide Hospital
Ferrol, A Coruña, 15405
Endocrinology and Nutrition Service, Hospital Central de Asturias
Oviedo, 33011
Endocrinology and Nutrition Unit /Diabetes Unit, Hospital General de Segovia
Segovia, 40002
About this study
Official title: Randomized Clinical Trial to Assess the Efficacy of the System Insulclock® 360 for Insulin Treatment Management in Type 1 Diabetes Patients With Insufficient Glycemic Control
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.
Read more
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.
Read the detailed description
Study design:
This multicentric randomized open-label study will be conducted at the Hospital General de Segovia (Segovia, Spain), Hospital de Cruces (Bilbao, Spain), Hospital Arquitecto Marcide (Ferrol, A Coruña, Spain) and Hospital Central de Asturias (Oviedo, Spain) after classification by the Spanish Agency for Medicines and Health Products (AEMPS) and ethical approval by the Ethics Review Committee of each research center. The study will be conducted in compliance with the ethical principles of the Declaration of Helsinki. Each participant will provide written informed consent before being included in the study.
The study is scheduled across seven visits. At Visit 1 (Screening, Week -1), demographic and clinical information will be collected, and concomitant medications will be registered. All potential study patients will be screened for eligibility after signing the informed consent form (ICF) and will be assigned with a patient identification number. Laboratory evaluations (HbA1c, serum chemistry) must be available within the last 2 months. An identification number will be assigned to each participant At Visit 2 (Run-in, week 0), participants will receive information on the use of the Insulclock device and app on masked mode (excluding the use of Insulclock 360 app information and alarms). If the participant does not use a CGM: a healthcare professional applies the FreeStyle Libre sensor to the back of the upper arm and activates it. If the participant already uses a CGM system, the patient will be encouraged to use sensors during this period.
At Visit 3 (First Visit CGM 1, week 1) and Visit 4 (Follow-up, week 3), participants will be encouraged to use the system At Visit 5 (Visit Starting CGM 2 and Randomization, week 4) participants will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Participants 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). Participants 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 and will be encouraged to wear the sensor for 2 weeks. Participants who already use a CGM system will be encouraged to use sensors during this period.
At Visit 6 (Final Visit CGM 2 and Randomization, week 6). Participants will receive a reminder on the use of Insulclock according to the corresponding group.
At Visit 7 (Final Visit, week 7) the mobile application diaries will be collected and reviewed. Participants will receive to fill in the Insulin Treatment Satisfaction Questionnaire (ITSQ) and the Diabetes Treatment Questionnaire (DTSQ).
Study population Investigators will include 80 participants aged 18-80 years with uncontrolled T1DM who provide written informed consent. Persistent uncontrolled T1DM was defined as HbA1C levels ≥6.5% for at least 1 year, and/or variations ≥1% in HbA1C within the previous 2 years and attending regular (more than 2 per year) follow-up visits at the Endocrinology department. Investigators will exclude pregnant or breastfeeding women, individuals with a history of or current alcohol or drug abuse, acute infection, cognitive decline or dementia, or any illness or condition that could interfere with the trial.
Study devices:
Insulclock is a small electronic device that works as an add-on module of insulin pens. This device can record the dose and time of insulin injected, register temperature changes of insulin pens, record the duration of an injection, and the specific insulin pen used. In the present study, participants self-administer insulin with pens coupled to Insulclock and according to routine clinical practice. By means of acoustic and visual alarms, participants receive information for a correct injection technique (an alert if the injection time was <6 seconds) or to prevent stacking insulin (an alert if a previous injection was done within the 2 previous hours).
The Insulclock device is synchronized with the Insulclock 360 app for the automatic logging of patient data. The Insulclock 360 app also has a reminder function to promote the timely administration of insulin doses. Users can also receive customized tips on DM management with the "my tutors" tool and obtain information on DM topics. Insulclock 360 app is compatible with Apple and Android operating systems.
In the Active group, participants will receive acoustic and visual alarms, device-related information and will have access to the Insulclock 360 app. In the Masked group, participants know the dose, time and duration of injections, but these participants will not receive any reminder and will be masked to the Insulclock 360 app.
Participants will use the Freestyle Libre (Abbott Diabetes Care, Witney, Oxon, UK) for the continuous monitoring of glucose levels. This flash continuous monitoring system is to be worn on the upper arm and does not require capillary glucose concentrations for calibration. The sensor automatically records glucose data every 15 minutes for 14 days.
Statistical Analysis The proposed statistical analysis methods constitute a synthesis of the methods to be used in this study to apply them to the data collected and respond to the general objective and the specific objectives.
Data from all participants included in the study, who meet the selection criteria, will be analyzed. Data in absentia will not be charged and will be considered as lost.
A general description of the variables included in the study will be made. The absolute and relative frequency distributions of the qualitative variables will be presented by investigators, as well as the measures of central tendency and dispersion (mean, standard deviation, median, minimum and maximum) of the quantitative variables. The confidence intervals will be presented at 95% for the main quantitative outcome variables associated with the main objective and the main secondary variables.
The data corresponding to the variables included in the main objective will be descriptively analyzed.
Investigators will use the SPSS software Version 17.0. to perform the analysis. The hypothesis tests that are carried out will be in all bilateral cases and with a significance level of 0.05. For variables that do not fit the normal distribution(or parametric), the Mann Whitney hypothesis tests will be used (for unpaired data). The chi-square test (or Fischer's exact test when appropriate) will be used for the analysis of contingency tables as well as for the comparison of proportions and/or frequency distributions.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Use of Insulclock system, both Insulclock device and Insulclock 360 app., Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1, Endocrine System Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 0 through week 7
Secondary outcomes (3)
Change in Mean glucose
Data are collected from the CGM of participants included in the active group, comparing mean glucose levels when patients were in the active group with the mean glucose levels obtained when these participants were included in the masked group.
Measured: Baseline, 7 weeks
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +6 = much more satisfied now to 0 = much less satisfied now, with 3 (midpoint), representing no change.
Measured: Baseline, 7 weeks
Change in Insulin Treatment Satisfaction Questionnaire (ITSQ-change) Score.
The ITSQ assesses the perceptions of patients on insulin treatment and their current treatment with insulin and how this affects their daily life.
ITSQ includes 7 domains: leisure activities, psychological barriers, handling, diabetes control, dependence, weight control, sleep. And 22 items scored on 7-point scales; scores range from +6 = much more satisfied now to 0 = much less satisfied now, with 3 (midpoint), representing no change.
Measured: Baseline, 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Segovia
- Sponsor type
- University, hospital or other
- Collaborators
- Insulcloud S.L.
- Responsible party
- Sponsor
- Investigators
- Fernando Gomez Peralta, Physician, Principal investigator, Hospital General de Segovia, Segovia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847778
- Sponsor's protocol ID
- INSULCLOCK2018
- Acronym
- Segoclock2
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21987347American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.
PubMed 26696682Borschuk 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.
PubMed 25984737Martyn-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.
PubMed 26439754Stolpe 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.
PubMed 27783551Peyrot 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.
PubMed 20103556Celik 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.
PubMed 25422134Arsand 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.
PubMed 25591859Klausmann 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.
PubMed 23630416Guo 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.
PubMed 22432521Danne 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.
PubMed 23294785Burdick 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.
PubMed 14993580Diabetes 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.
PubMed 8366922Phan 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.
PubMed 24062334Luo 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.
PubMed 29663623
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Assess the Efficacy of the System Insulclock® 360 for Insulin Treatment Management in Type 1 Diabetes Patients With Insufficient Glycemic Control
- ClinicalTrials.gov ID
- NCT04847778
- Acronym / sponsor ID
- Segoclock2 / INSULCLOCK2018
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes Mellitus, Insulin Pen, Glycosylated Hemoglobin, Time in Range, Adherence, Continuous Glucose Monitoring, Insulclock, Basal glycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital General de SegoviaUniversity, hospital or other
- Collaborators
- Insulcloud S.L.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design:
This multicentric randomized open-label study will be conducted at the Hospital General de Segovia (Segovia, Spain), Hospital de Cruces (Bilbao, Spain), Hospital Arquitecto Marcide (Ferrol, A Coruña, Spain) and Hospital Central de Asturias (Oviedo, Spain) after classification by the Spanish Agency for Medicines and Health Products (AEMPS) and ethical approval by the Ethics Review Committee of each research center. The study will be conducted in compliance with the ethical principles of the Declaration of Helsinki. Each participant will provide written informed consent before being included in the study.
The study is scheduled across seven visits. At Visit 1 (Screening, Week -1), demographic and clinical information will be collected, and concomitant medications will be registered. All potential study patients will be screened for eligibility after signing the informed consent form (ICF) and will be assigned with a patient identification number. Laboratory evaluations (HbA1c, serum chemistry) must be available within the last 2 months. An identification number will be assigned to each participant At Visit 2 (Run-in, week 0), participants will receive information on the use of the Insulclock device and app on masked mode (excluding the use of Insulclock 360 app information and alarms). If the participant does not use a CGM: a healthcare professional applies the FreeStyle Libre sensor to the back of the upper arm and activates it. If the participant already uses a CGM system, the patient will be encouraged to use sensors during this period.
At Visit 3 (First Visit CGM 1, week 1) and Visit 4 (Follow-up, week 3), participants will be encouraged to use the system At Visit 5 (Visit Starting CGM 2 and Randomization, week 4) participants will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Participants 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). Participants 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 and will be encouraged to wear the sensor for 2 weeks. Participants who already use a CGM system will be encouraged to use sensors during this period.
At Visit 6 (Final Visit CGM 2 and Randomization, week 6). Participants will receive a reminder on the use of Insulclock according to the corresponding group.
At Visit 7 (Final Visit, week 7) the mobile application diaries will be collected and reviewed. Participants will receive to fill in the Insulin Treatment Satisfaction Questionnaire (ITSQ) and the Diabetes Treatment Questionnaire (DTSQ).
Study population Investigators will include 80 participants aged 18-80 years with uncontrolled T1DM who provide written informed consent. Persistent uncontrolled T1DM was defined as HbA1C levels ≥6.5% for at least 1 year, and/or variations ≥1% in HbA1C within the previous 2 years and attending regular (more than 2 per year) follow-up visits at the Endocrinology department. Investigators will exclude pregnant or breastfeeding women, individuals with a history of or current alcohol or drug abuse, acute infection, cognitive decline or dementia, or any illness or condition that could interfere with the trial.
Study devices:
Insulclock is a small electronic device that works as an add-on module of insulin pens. This device can record the dose and time of insulin injected, register temperature changes of insulin pens, record the duration of an injection, and the specific insulin pen used. In the present study, participants self-administer insulin with pens coupled to Insulclock and according to routine clinical practice. By means of acoustic and visual alarms, participants receive information for a correct injection technique (an alert if the injection time was <6 seconds) or to prevent stacking insulin (an alert if a previous injection was done within the 2 previous hours).
The Insulclock device is synchronized with the Insulclock 360 app for the automatic logging of patient data. The Insulclock 360 app also has a reminder function to promote the timely administration of insulin doses. Users can also receive customized tips on DM management with the "my tutors" tool and obtain information on DM topics. Insulclock 360 app is compatible with Apple and Android operating systems.
In the Active group, participants will receive acoustic and visual alarms, device-related information and will have access to the Insulclock 360 app. In the Masked group, participants know the dose, time and duration of injections, but these participants will not receive any reminder and will be masked to the Insulclock 360 app.
Participants will use the Freestyle Libre (Abbott Diabetes Care, Witney, Oxon, UK) for the continuous monitoring of glucose levels. This flash continuous monitoring system is to be worn on the upper arm and does not require capillary glucose concentrations for calibration. The sensor automatically records glucose data every 15 minutes for 14 days.
Statistical Analysis The proposed statistical analysis methods constitute a synthesis of the methods to be used in this study to apply them to the data collected and respond to the general objective and the specific objectives.
Data from all participants included in the study, who meet the selection criteria, will be analyzed. Data in absentia will not be charged and will be considered as lost.
A general description of the variables included in the study will be made. The absolute and relative frequency distributions of the qualitative variables will be presented by investigators, as well as the measures of central tendency and dispersion (mean, standard deviation, median, minimum and maximum) of the quantitative variables. The confidence intervals will be presented at 95% for the main quantitative outcome variables associated with the main objective and the main secondary variables.
The data corresponding to the variables included in the main objective will be descriptively analyzed.
Investigators will use the SPSS software Version 17.0. to perform the analysis. The hypothesis tests that are carried out will be in all bilateral cases and with a significance level of 0.05. For variables that do not fit the normal distribution(or parametric), the Mann Whitney hypothesis tests will be used (for unpaired data). The chi-square test (or Fischer's exact test when appropriate) will be used for the analysis of contingency tables as well as for the comparison of proportions and/or frequency distributions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Masked arm | Active comparator | Device: Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.* 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. |
| Active arm | Active comparator | 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.* 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. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- age range: 14 to 80 years
- DM1 diagnosed
- Patients with type 1 diabetes and poor glycemic control, defined as:
- Signed informed consent form
- Ability of the subjects to use the system and fill the included questionnaires
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Insulclock system, both Insulclock device and Insulclock 360 app.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. | Device | Active arm |
| Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.Visit 5, during week 4. Randomization will be applied: Masked group will remain with the masked system, without functionalities. | Device | Active arm, Masked arm |
Primary outcome
Change in "Time In Range" (TIR)
Time frame: Baseline, 7 weeks
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.
Number of daily insulin injections irregularities
Time frame: Week 0 through week 7
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.
3 secondary outcomes
Change in Mean glucose
Time frame: Baseline, 7 weeks
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
Time frame: Baseline, 7 weeks
Change in Insulin Treatment Satisfaction Questionnaire (ITSQ-change) Score.
Time frame: Baseline, 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 21987347Soriguer 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.
- Background: PubMed 26696682American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.
- Background: PubMed 25984737Borschuk 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.
- Background: PubMed 26439754Martyn-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.
- Background: PubMed 27783551Stolpe 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.
- Background: PubMed 20103556Peyrot 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.
- Background: PubMed 25422134Celik 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.
- Background: PubMed 25591859Arsand 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.
- Background: PubMed 23630416Klausmann 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.
- Background: PubMed 22432521Guo 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.
- Background: PubMed 23294785Danne 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.
- Background: PubMed 14993580Burdick 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.
- Homepage of the Insuclock device and Insulclock 360 appLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Gomez Peralta, Physician principal investigator
Hospital General de Segovia, Segovia, Spain
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Insulclock system, both Insulclock device and Insulclock 360 app. and Use of Insulclock system, both Insulclock device and Insulclock app on masked mode. in people with Diabetes Mellitus, Type 1, run by Hospital General de Segovia at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "Time In Range" (TIR) (time frame: Baseline, 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847778, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.