NCT06845891: CAPSDM1

Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus

Completed Phase 4 Last updated 15 September 2025

What this trial tests

Phase 4 trial testing CONNECTED SMART CAP in Type 1 Diabetes Mellitus in 42 participants. Completed in 19 June 2025.

Timeline

26 February 2025

Primary endpoint
19 June 2025

19 June 2025

Quick facts

Lead sponsor	Fernando Sebastián Valles
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	26 February 2025
Primary completion	19 June 2025
Estimated completion	19 June 2025
Sites	1 location across Spain

Drugs / interventions tested

• CONNECTED SMART CAP

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
• Type 1 Diabetes Mellitus (T1DM) — all drugs for Type 1 Diabetes Mellitus (T1DM) →
• Diabetes Management — all drugs for Diabetes Management →

Sponsor

Fernando Sebastián Valles

Who can join

18 and older, any sex, with Type 1 Diabetes Mellitus or Type 1 Diabetes Mellitus (T1DM). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Sebastian-Valles F, Sager-La Ganga C, Justel Enriquez A, Jimenez Blanco S, et al · · 2026 · cited 1× · PMID 41634174 · DOI 10.1007/s00125-026-06674-w