N/A
Completed N=21
DailyDose Smart Snack Study for T1D on MDI
Type 1 Diabetes Mellitus With Hypoglycemia
Source: ClinicalTrials.gov NCT05967260 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Probability of Overnight Hypoglycemia — 23.6; 26.0 percentage of nights
Summary
This is a single-center, open-label, crossover trial with two arms and two periods (2x2) and one-week washout period. The study is designed to evaluate the efficacy of an AI-based bedtime smart snack intervention in reducing nocturnal low glucose in people living with T1D on MDI therapy compared with traditional CGM-augmented MDI therapy as the control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Overnight Hypoglycemia |
23.6; 26.0 | — |
| SECONDARY Time to the First Overnight Low-glucose Event (<70 mg/dL) |
2.8; 3.3 | — |
| SECONDARY Percentage of Time With Sensed Glucose Less Than 54 mg/dL (Overnight) |
1.0; 1.3 | — |
| SECONDARY Percentage of Time With Sensed Glucose Less Than 54 mg/dL (24-hour/Day Study Duration) |
0.7; 0.7 | — |
| SECONDARY Percentage of Time With Sensed Glucose Less Than 70 mg/dL (Overnight) |
4.2; 4.7 | — |
| SECONDARY Percentage of Time With Sensed Glucose Less Than 70 mg/dL (24-hour/Day Study Duration) |
3.2; 3.1 | — |
| SECONDARY Percentage of Time With Sensed Glucose Between 70-180 mg/dL (Overnight) |
64.0; 61.8 | — |
| SECONDARY Percentage of Time With Sensed Glucose Between 70-180 mg/dL (24-hour/Day Study Duration) |
63.9; 61.4 | — |
| SECONDARY Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (Overnight) |
31.7; 33.5 | — |
| SECONDARY Percentage of Time With Sensed Glucose Greater Than 180 mg/dL (24-hour/Day Study Duration) |
32.8; 35.5 | — |
| SECONDARY Percentage of Time Sensed Glucose Greater Than 250 mg/dL (Overnight) |
10.2; 9.7 | — |
| SECONDARY Percentage of Time Sensed Glucose Greater Than 250 mg/dL (24-hour/Day Study Duration) |
10.4; 11.3 | — |
| SECONDARY Mean Sensed Glucose (Overnight) |
159.0; 160.4 | — |
| SECONDARY Mean Sensed Glucose (24-hour/Day Study Duration) |
161.9; 165.2 | — |
| SECONDARY Accuracy of Overnight Low Glucose Prediction by Sensitivity |
71.6 | — |
| SECONDARY Accuracy of Overnight Low Glucose Prediction by Specificity |
56.8 | — |
| SECONDARY Change in Weight |
-2.1; -0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 1 diabetes mellitus for at least 1 year
- Male or female participants 18 years of age or older
- Using multiple daily injections
- HbA1c <10% at screening
- Current use of a continuous glucose monitoring system with at least two episodes of overnight hypoglycemia (defined as sensed glucose <70 mg/dL for at least 10 minutes between the hours of 10 PM and 6 AM) within 30 days prior to screening
- Individuals with history of severe hypoglycemia requiring third party assistance must have a companion in the same dwelling as the study participant who will be linked to the participant's Dexcom app during the control arm of the study, and who is trained in the administration of glucagon.
- Willingness to follow all study procedures
- Willingness to sign informed consent and HIPAA documents
Exclusion Criteria
- Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence
- Any active infection
- Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use)
- Seizure disorder
- Use of non-insulin glucose lowering medications
- Use of steroids
- Stage-three or more advanced chronic kidney disease
- Hypo- or hyper- thyroidism that is not medically optimized and on a stable regimen define as Thyroid-stimulating hormone (TSH) outside of the normal reference range based on screening labs
- Adrenal insufficiency
- Cirrhosis
- Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol
- Individual working night shifts
Data sourced from ClinicalTrials.gov (NCT05967260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.