Skeletal Muscle Health in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this research study is to find out if Type 1 Diabetes (T1D) affects skeletal
      muscle health and if we can improve glycemic control by improving skeletal muscle health.
      Participants in this study will have a blood sample and a urine sample collected after taking
      a single dose of a nontoxic chemical called D3-creatine. Their body composition will be
      measured by a scale like device. Parents of participating children will also be asked to
      complete a food and activity questionnaire.

      Participants will be in the study for roughly 12 to 24 months. Enrollment will begin once
      participant signs the consent form. At the 12 month follow-up visit participants will be
      asked to wear a Garmin physical activity monitor and use the Garmin Connect mobile app for a
      period of up to 12 months and take a one time Muscle Strength Measurement test.

      The greatest risks of this study include the possibility of loss of confidentiality.
    

Detailed description: 
      Physical Activity Monitor:

      This research will look at the relationship of physical activity on skeletal muscle health,
      by using a Physical Activity Monitor (Garmin vívofit 3): At the 12 month follow-up visit
      study participant will be asked to wear a Garmin physical activity monitor and use the Garmin
      Connect mobile app for a period of up to 12 months. The Garmin Connect app will be downloaded
      onto the parent or guardian's smartphone or tablet. The study team will create a unique
      study-specific Duke email (e.g. SMHparticipantXXX@duke.edu) and an assign a unique password
      for each participant. Passwords will be assigned in accordance with applicable Duke Health
      password security policy requirements. This email address and password will be used solely
      for account creation and will not be used for communication. No personal information will be
      used in the study-specific email or password. Study participants are advised to limit
      personal identifiers entered into mobile applications/third party software only to those that
      you wish to voluntarily share with others. Study participant is under no obligation to
      participate in this phase of the study, as is the case with all research, this sub-study is
      100% voluntary.

      Measurement of Muscle Strength:

      Upper and lower body strength will be measured using tools that give the researchers a
      snapshot of the strength in specific muscle groups. Participant will be asked to grip or
      pinch or push or pull against a device that measures the force they generate when doing these
      tasks, to measure their strength. In addition to muscle strength testing we will be measuring
      functional endurance by having participant walk for 6 minutes to see how far they can walk in
      6 minutes. These measurements will be taken by a physical therapist in coordination with
      regularly scheduled appointments.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cohort will consist of 25 young, prepubertal and very early pubertal (Tanner stages 1 and
        2) children (13 females and 12 males) with early onset T1D