Type 1 Diabetes MellitusCAPSDM1NCT06845891
Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus
A study testing CONNECTED SMART CAP in people with Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus (T1DM), run by Fernando Sebastián Valles at 1 site in Spain.
Trial summary
This clinical study evaluates the impact of the Cap INSULCLOCK device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (T1DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus (T1DM), Diabetes Management
- What is being tested?
- CONNECTED SMART CAP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2025to 19 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or older.
- Diagnosis of type 1 diabetes mellitus (T1DM).
- Users of flash continuous glucose monitoring (FGM) sensors with >70% of recorded data, including intake and insulin dose logs.
- Adequate therapeutic adherence, with no missed appointments in the past year.
- Time above range (TAR >180 mg/dL) >25%.
- Ability to provide informed consent to participate in the study.
- Access to technology for follow-up, including a smartphone with internet connectivity and compatibility with the Insulcloud app.
Who cannot join
- Current pregnancy.
- Severe acute illness.
- Exclusion criteria for the use of real-time continuous glucose monitoring (RT-CGM) systems as per the Framework Agreement of the Community of Madrid for RT-CGM use (SERMAS).
- Inability to provide informed consent or to meet the study requirements for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estudio clínico: Analisis de Control Glucemico y Satisfaccion Con un Cap Conectado en Pacientes Con dm Tipo 1
This clinical study evaluates the impact of the Cap INSULCLOCK device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (T1DM). Despite advances in pharmacology and technology, a significant proportion of individuals with T1DM fail to achieve recommended glycemic targets, partly due to the complexity of insulin therapy and suboptimal adherence. Cap INSULCLOCK is a device that attaches to insulin pens, automatically recording injections and integrating data on glucose levels, insulin administration, food intake, and physical activity, with real-time Bluetooth transmission. Its use may enhance adherence and optimize metabolic control.
This study is a randomized, low-intervention clinical trial conducted at a single center, enrolling 42 patients, who will be randomized into two groups: one using the activated device and a control group using the device in a blinded mode. The primary objective is to assess differences in time above range (TAR >180 mg/dL) over the last 14 days of continuous glucose monitoring (CGM). Secondary objectives include evaluating HbA1c levels, time in range (TIR), frequency of hypoglycemic episodes, and patient satisfaction. Data will be analyzed using advanced statistical methods, and the intervention is expected to improve adherence, reduce glycemic variability, and enhance quality of life in individuals with T1DM
- Being tested
- CONNECTED SMART CAP
- Keywords
- diabetes tecnhology, Type 1 diabetes, Smart cap, Time above range
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECTED SMART CAPDevice
The intervention in this study consists of attaching a smart cap to the insulin pen of individuals with type 1 diabetes who use flash glucose monitoring and experience a time above range (TAR >180 mg/dL) for more than 25% of the time. This metric has been associated with diabetes-related complications, and the objective of this study is to determine whether this simple device could help reduce this underexplored parameter.
| Study group | Role | What they receive |
|---|---|---|
| Connected smart cap | Experimental | This arm will have access to the cap, which is connected to the digital application that records the timing of insulin injections and provides reminders in case of missed doses. Receives: Device: CONNECTED SMART CAP |
| cap disconnected | Active comparator | This treatment arm will receive the cap without connectivity, thereby lacking access to the information provided by the digital application, including the timing of insulin injections, injection events, and reminder notifications. Receives: Device: CONNECTED SMART CAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Above Range >180 mg/dL
Time Above Range (TAR) refers to the percentage of time that an individual's glucose levels exceed 180 mg/dL during a given period, in this case, the last 14 days as recorded by a continuous or flash glucose monitoring system. This metric reflects hyperglycemic burden and has been associated with an increased risk of diabetes-related complications. Clinical guidelines generally recommend keeping TAR below 25% to optimize glycemic control and reduce long-term adverse outcomes.
Measured: 14 days
Secondary outcomes (1)
Time in range (70 - 180 mg/dL),
Time in Range (TIR) refers to the percentage of time an individual's glucose levels remain within the target range of 70-180 mg/dL over the last 14 days, as recorded by a continuous or flash glucose monitoring system. TIR is a key glycemic metric reflecting overall glucose control, with higher percentages being associated with a lower risk of diabetes-related complications. Clinical guidelines recommend maintaining TIR above 70% as a primary therapeutic goal for individuals with diabetes.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start26 Feb 2025
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernando Sebastián Valles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernando Sebastián Valles, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845891
- Sponsor's protocol ID
- 5350
- Other IDs
- 5350
- Acronym
- CAPSDM1
- Status last verified
- Sep 2025
- First submitted
- 17 Feb 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to ethical and regulatory considerations regarding patient confidentiality
Publications
Sebastian-Valles F, Sager-La Ganga C, Justel Enriquez A, Jimenez Blanco S, Navas-Moreno V, Arranz Martin JA, Marazuela M. Analysis of glycaemic control and treatment satisfaction with a connected smart pen cap in adults with type 1 diabetes: a randomised, open-label, parallel-group trial. Diabetologia. 2026 May;69(5):1191-1204. doi: 10.1007/s00125-026-06674-w. Epub 2026 Feb 3.
PubMed 41634174
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio clínico: Analisis de Control Glucemico y Satisfaccion Con un Cap Conectado en Pacientes Con dm Tipo 1
- ClinicalTrials.gov ID
- NCT06845891
- Acronym / sponsor ID
- CAPSDM1 / 5350
- Keywords
- diabetes tecnhology, Type 1 diabetes, Smart cap, Time above range
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fernando Sebastián VallesUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 25 Feb 2025 (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.
This clinical study evaluates the impact of the Cap INSULCLOCK device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (T1DM). Despite advances in pharmacology and technology, a significant proportion of individuals with T1DM fail to achieve recommended glycemic targets, partly due to the complexity of insulin therapy and suboptimal adherence. Cap INSULCLOCK is a device that attaches to insulin pens, automatically recording injections and integrating data on glucose levels, insulin administration, food intake, and physical activity, with real-time Bluetooth transmission. Its use may enhance adherence and optimize metabolic control.
This study is a randomized, low-intervention clinical trial conducted at a single center, enrolling 42 patients, who will be randomized into two groups: one using the activated device and a control group using the device in a blinded mode. The primary objective is to assess differences in time above range (TAR >180 mg/dL) over the last 14 days of continuous glucose monitoring (CGM). Secondary objectives include evaluating HbA1c levels, time in range (TIR), frequency of hypoglycemic episodes, and patient satisfaction. Data will be analyzed using advanced statistical methods, and the intervention is expected to improve adherence, reduce glycemic variability, and enhance quality of life in individuals with T1DM
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connected smart cap | Experimental | Device: CONNECTED SMART CAPThis arm will have access to the cap, which is connected to the digital application that records the timing of insulin injections and provides reminders in case of missed doses. |
| cap disconnected | Active comparator | Device: CONNECTED SMART CAPThis treatment arm will receive the cap without connectivity, thereby lacking access to the information provided by the digital application, including the timing of insulin injections, injection events, and reminder notifications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 18 years or older.
- Diagnosis of type 1 diabetes mellitus (T1DM).
- Users of flash continuous glucose monitoring (FGM) sensors with >70% of recorded data, including intake and insulin dose logs.
- Adequate therapeutic adherence, with no missed appointments in the past year.
- Time above range (TAR >180 mg/dL) >25%.
Key exclusion criteria (4 listed)
- Current pregnancy.
- Severe acute illness.
- Exclusion criteria for the use of real-time continuous glucose monitoring (RT-CGM) systems as per the Framework Agreement of the Community of Madrid for RT-CGM use (SERMAS).
- Inability to provide informed consent or to meet the study requirements for any reason.
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 |
|---|---|---|
| CONNECTED SMART CAPThe intervention in this study consists of attaching a smart cap to the insulin pen of individuals with type 1 diabetes who use flash glucose monitoring and experience a time above range (TAR >180 mg/dL) for more than 25% of the time. This metric has been associated with diabetes-related complications, and the objective of this study is to determine whether this simple device could help reduce this underexplored parameter. | Device | Connected smart cap, cap disconnected |
Primary outcome
Time Above Range >180 mg/dL
Time frame: 14 days
Time Above Range (TAR) refers to the percentage of time that an individual's glucose levels exceed 180 mg/dL during a given period, in this case, the last 14 days as recorded by a continuous or flash glucose monitoring system. This metric reflects hyperglycemic burden and has been associated with an increased risk of diabetes-related complications. Clinical guidelines generally recommend keeping TAR below 25% to optimize glycemic control and reduce long-term adverse outcomes.
1 secondary outcome
Time in range (70 - 180 mg/dL),
Time frame: 14 days
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 17 Sep 2026.
- Derived from this study: PubMed 41634174Sebastian-Valles F, Sager-La Ganga C, Justel Enriquez A, Jimenez Blanco S, Navas-Moreno V, Arranz Martin JA, Marazuela M. Analysis of glycaemic control and treatment satisfaction with a connected smart pen cap in adults with type 1 diabetes: a randomised, open-label, parallel-group trial. Diabetologia. 2026 May;69(5):1191-1204. doi: 10.1007/s00125-026-06674-w. Epub 2026 Feb 3.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to ethical and regulatory considerations regarding patient confidentiality
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONNECTED SMART CAP in people with Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus (T1DM), run by Fernando Sebastián Valles at 1 site 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 7 inclusion and 4 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time Above Range >180 mg/dL (time frame: 14 days). 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 NCT06845891, which also lists 1 linked publication.
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 17 Sep 2026.